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Beckman Coulter, Inc. FDA Approvals
0 new drug approvals and 53 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Access NT-proBNP510(k)Sep 21, 2026Clinical Chemistry |
| Access BNP II510(k)Mar 24, 2026Clinical Chemistry |
| Access anti-HBc IgM510(k)Mar 13, 2026Microbiology |
| Access anti-HBc Total510(k)Feb 19, 2026Microbiology |
| Access anti-HAV IgM510(k)Jan 27, 2026Microbiology |
| Access Rubella IgG510(k)Nov 17, 2025Microbiology |
| iQ200 Series510(k)Sep 10, 2025Hematology |
| Access anti-HAV510(k)Sep 9, 2025Microbiology |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)510(k)Aug 20, 2025Microbiology |
| MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)510(k)Aug 15, 2025Microbiology |
| Access hsTnI510(k)Aug 1, 2025Clinical Chemistry |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)510(k)Jul 18, 2025Microbiology |
| Access hsTnI510(k)Jun 16, 2025Clinical Chemistry |
| Access Toxo IgG510(k)Mar 28, 2025Microbiology |
| Access Cortisol; DxC 500i Clinical Analyzer510(k)Mar 5, 2025Clinical Chemistry |
| Access Toxo IgM II510(k)Oct 11, 2024Microbiology |
| Access Syphilis510(k)Sep 6, 2024Microbiology |
| Access TPO Antibody510(k)Aug 9, 2024Immunology |
| UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System510(k)Jul 5, 2024Hematology |
| Access sTfR510(k)Jul 3, 2024Immunology |
| Access Thyroglobulin Antibody II510(k)Jul 3, 2024Immunology |
| Access Thyroglobulin510(k)Jun 28, 2024Immunology |
| Access Thyroglobulin510(k)Jun 7, 2024Immunology |
| Access OV Monitor510(k)May 10, 2024Immunology |
| Access BR Monitor510(k)May 9, 2024Immunology |
| Access Intrinsic Factor Ab510(k)May 3, 2024Clinical Chemistry |
| Access EPO510(k)Apr 22, 2024Hematology |
| Access NT-proBNP510(k)Apr 12, 2024Clinical Chemistry |
| Access Ferritin510(k)Mar 20, 2024Immunology |
| Access Free T4510(k)Mar 6, 2024Clinical Chemistry |
| Access Intact PTH510(k)Mar 1, 2024Clinical Chemistry |
| Access CK-MB510(k)Feb 16, 2024Clinical Chemistry |
| Access SHBG510(k)Feb 8, 2024Clinical Chemistry |
| Access hsTnI510(k)Dec 18, 2023Clinical Chemistry |
| Access hsTnI510(k)Dec 4, 2023Clinical Chemistry |
| DxFLEX Flow Cytometer; ClearLLab 10C Panels510(k)Nov 22, 2023Hematology |
| Access Thyroglobulin Antibody II510(k)Sep 26, 2023Immunology |
| Access CEA510(k)Sep 22, 2023Immunology |
| Access Myoglobin510(k)Sep 18, 2023Immunology |
| Access Thyroglobulin510(k)Sep 15, 2023Immunology |
| Access Folate Assay510(k)Aug 23, 2023Clinical Chemistry |
| Access PCT510(k)Apr 26, 2023Microbiology |
| MicroScan Prompt Inoculation System-D510(k)Apr 5, 2023Microbiology |
| Access Cortisol510(k)Feb 8, 2023Clinical Chemistry |
| Access AMH510(k)Feb 3, 2023Clinical Chemistry |
| Access 25(OH) Vitamin D Total510(k)Jan 19, 2023Clinical Chemistry |
| Access Testosterone510(k)Jan 13, 2023Clinical Chemistry |
| Access Total ßhCG (5th IS)510(k)Dec 27, 2022Clinical Chemistry |
| Access Vitamin B12510(k)Dec 23, 2022Clinical Chemistry |
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer510(k)Nov 10, 2022Clinical Chemistry |
| Total Immunoglobulin E (IgE)510(k)Mar 23, 2022Immunology |
| iQ200 System, iChemVELOCITY Automated Urine Chemistry System510(k)Jul 2, 2021Hematology |
| MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)510(k)May 18, 2021Microbiology |