FDA product code GOK: Antisera, Hai (Including Hai Control), Rubella
GOK is the FDA product code for antisera, hai (including hai control), rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under GOK, from 8 different applicants. The average 510(k) review took 48 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Hai (Including Hai Control), Rubella |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GOK clearance
Top GOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microbiological Assoc. | 2 | 1980-01-11 |
| Organon, Inc. | 2 | 1979-02-15 |
| Flow Laboratories, Inc. | 2 | 1977-10-28 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1983-09-29 |
| Abbott Laboratories | 1 | 1981-05-05 |
3 more applicants have GOK clearances. See the full list in Caduvo.
Most recent GOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832228 | Bd Becton Dickinson Vacutainer Systems Preanalytic | RUBASCAN LATEX CARD TEST | 1983-09-29 | 80 |
| K810835 | Abbott Laboratories | RUBAZYME - M | 1981-05-05 | 41 |
| K792635 | Electro-Nucleonics Laboratories, Inc. | ANTIBODY TO RUBELLA VIRUS | 1980-03-19 | 91 |
| K792133 | Microbiological Assoc. | RUBELISA TEST KIT | 1980-01-11 | 81 |
| K790122 | Organon, Inc. | RUBANON | 1979-02-15 | 23 |
Recalls for GOK devices
openFDA lists no recalls for product code GOK.
Frequently asked questions
What is FDA product code GOK?
GOK is the FDA product code for antisera, hai (including hai control), rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is GOK?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code GOK?
Across 11 cleared submissions the average was 48 days from receipt to decision (median 41).
Which companies have the most GOK clearances?
Microbiological Assoc. (2); Organon, Inc. (2); Flow Laboratories, Inc. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Abbott Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GOK
- Run a recall and safety report across every GOK manufacturer
- Watch product code GOK 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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