FDA product code GQC: Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
GQC is the FDA product code for antisera, cf, equine encephalitis virus, eee, wee. It is a Class I device, regulated under 21 CFR 866.3240 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GQC. The average 510(k) review took 478 days (median 478).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, Equine Encephalitis Virus, Eee, Wee |
| Device class | Class I |
| Regulation | 21 CFR 866.3240 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GQC clearance
Top GQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hillcrest Biologicals | 2 | 1992-12-03 |
Most recent GQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913617 | Hillcrest Biologicals | ARBOVIRUS IGG IFA TEST | 1992-12-03 | 478 |
| K913618 | Hillcrest Biologicals | ARBOVIRUS IGM IFA TEST | 1992-12-03 | 478 |
Recalls for GQC devices
openFDA lists no recalls for product code GQC.
Frequently asked questions
What is FDA product code GQC?
GQC is the FDA product code for antisera, cf, equine encephalitis virus, eee, wee. It is a Class I device, regulated under 21 CFR 866.3240 and reviewed by the Microbiology panel.
What device class is GQC?
Class I, regulation 21 CFR 866.3240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GQC?
Across 2 cleared submissions the average was 478 days from receipt to decision (median 478).
Which companies have the most GQC clearances?
Hillcrest Biologicals (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GQC
- Run a recall and safety report across every GQC manufacturer
- Watch product code GQC 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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