FDA product code GSQ: Antiserum, Vibrio Cholerae, All Varieties
GSQ is the FDA product code for antiserum, vibrio cholerae, all varieties. It is a Class II device, regulated under 21 CFR 866.3930 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GSQ, from 2 different applicants. The average 510(k) review took 415 days (median 289).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Vibrio Cholerae, All Varieties |
| Device class | Class II |
| Regulation | 21 CFR 866.3930 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GSQ clearance
Top GSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| New Horizons Diagnostics Co. | 2 | 1995-06-27 |
| Guardian Scientific, Corp. | 1 | 1996-08-15 |
Most recent GSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954995 | Guardian Scientific, Corp. | QUIX RAPID CHOLERA STRIP TEST | 1996-08-15 | 289 |
| K932622 | New Horizons Diagnostics Co. | CHOLERA SMART(TM) | 1995-06-27 | 756 |
| K922432 | New Horizons Diagnostics Co. | CHOLERASCREEN | 1992-12-07 | 199 |
Recalls for GSQ devices
openFDA lists no recalls for product code GSQ.
Frequently asked questions
What is FDA product code GSQ?
GSQ is the FDA product code for antiserum, vibrio cholerae, all varieties. It is a Class II device, regulated under 21 CFR 866.3930 and reviewed by the Microbiology panel.
What device class is GSQ?
Class II, regulation 21 CFR 866.3930. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSQ?
Across 3 cleared submissions the average was 415 days from receipt to decision (median 289).
Which companies have the most GSQ clearances?
New Horizons Diagnostics Co. (2); Guardian Scientific, Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GSQ
- Run a recall and safety report across every GSQ manufacturer
- Watch product code GSQ 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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