FDA product code GSA: Antisera, All Mycoplasma Spp.
GSA is the FDA product code for antisera, all mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under GSA, from 5 different applicants. The average 510(k) review took 120 days (median 106).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Mycoplasma Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3375 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GSA clearance
Top GSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Diagnostic Technologies, Inc. | 2 | 1988-10-25 |
| Shared Systems, Inc. | 1 | 1995-10-17 |
| Seradyn, Inc. | 1 | 1991-06-24 |
| Meridian Diagnostics, Inc. | 1 | 1991-01-30 |
| Intl. Mycoplasma/Mdc Assoc. | 1 | 1990-12-21 |
Most recent GSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950073 | Shared Systems, Inc. | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | 1995-10-17 | 281 |
| K910833 | Seradyn, Inc. | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | 1991-06-24 | 117 |
| K905493 | Meridian Diagnostics, Inc. | MERISTAR-MP | 1991-01-30 | 54 |
| K903958 | Intl. Mycoplasma/Mdc Assoc. | SEROFAST | 1990-12-21 | 115 |
| K883083 | Medical Diagnostic Technologies, Inc. | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | 1988-10-25 | 96 |
Recalls for GSA devices
openFDA lists no recalls for product code GSA.
Frequently asked questions
What is FDA product code GSA?
GSA is the FDA product code for antisera, all mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel.
What device class is GSA?
Class I, regulation 21 CFR 866.3375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSA?
Across 6 cleared submissions the average was 120 days from receipt to decision (median 106).
Which companies have the most GSA clearances?
Medical Diagnostic Technologies, Inc. (2); Shared Systems, Inc. (1); Seradyn, Inc. (1); Meridian Diagnostics, Inc. (1); Intl. Mycoplasma/Mdc Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GSA
- Run a recall and safety report across every GSA manufacturer
- Watch product code GSA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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