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Plasmapp Co,., Ltd. FDA Approvals

0 new drug approvals and 8 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
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)510(k)May 25, 2023General Hospital
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette510(k)May 9, 2023General Hospital
Tyvek Roll with CI for STERLINK Sterilizer510(k)May 9, 2023General Hospital
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)510(k)May 9, 2023General Hospital
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)510(k)Apr 14, 2023General Hospital
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette510(k)Oct 22, 2021General Hospital
Tyvek(R) Roll with CI for STERLINKTM Sterilizer510(k)Oct 22, 2021General Hospital
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)510(k)Oct 22, 2021General Hospital

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