510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GSAClass I

Antisera, All Mycoplasma Spp.

21 CFR 866.3375 / Microbiology
FDA source (opens on fda.gov)

GSA is the FDA product code for Antisera, All Mycoplasma Spp., a class I device type, regulated under 21 CFR 866.3375. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GSA
Device name
Antisera, All Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code GSA

By decision year
6 clearances under product code GSA with a decision year between 1986 and 1995, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GSA by decision year
YearClearances
19861
19881
19901
19912
19951

Applicants with the most clearances

Product code GSA
Applicants holding the most 510(k) clearances under product code GSA
ApplicantClearances
Medical Diagnostic Technologies, Inc.2
Intl. Mycoplasma/Mdc Assoc.1
Meridian Diagnostics, Inc.1
Seradyn, Inc.1
Shared Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code