FDA product code GOG: Antisera, Cf, Poliovirus 1-3
GOG is the FDA product code for antisera, cf, poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GOG, from 3 different applicants. The average 510(k) review took 143 days (median 154).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, Poliovirus 1-3 |
| Device class | Class I |
| Regulation | 21 CFR 866.3405 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GOG clearance
Top GOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 1 | 2007-10-18 |
| Thermo Biostar, Inc. | 1 | 2002-09-13 |
| Hillcrest Biologicals | 1 | 1985-11-07 |
Most recent GOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071101 | Meridian Bioscience, Inc. | TRU RSV | 2007-10-18 | 182 |
| K021172 | Thermo Biostar, Inc. | RSV OIA | 2002-09-13 | 154 |
| K853278 | Hillcrest Biologicals | POLIO TYPE I CF ANTIGEN, & TYPE II, III | 1985-11-07 | 94 |
Recalls for GOG devices
openFDA lists no recalls for product code GOG.
Frequently asked questions
What is FDA product code GOG?
GOG is the FDA product code for antisera, cf, poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel.
What device class is GOG?
Class I, regulation 21 CFR 866.3405. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GOG?
Across 3 cleared submissions the average was 143 days from receipt to decision (median 154).
Which companies have the most GOG clearances?
Meridian Bioscience, Inc. (1); Thermo Biostar, Inc. (1); Hillcrest Biologicals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GOG
- Run a recall and safety report across every GOG manufacturer
- Watch product code GOG 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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