GOK — Antisera, Hai (Including Hai Control), Rubella Class II
FDA product code GOK covers "Antisera, Hai (Including Hai Control), Rubella", a Class II medical device regulated under 21 CFR 866.3510. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GOK
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K832228 | bd becton dickinson vacutainer systems preanalytic | RUBASCAN LATEX CARD TEST | September 29, 1983 |
| K810835 | abbott laboratories | RUBAZYME - M | May 5, 1981 |
| K792635 | electro-nucleonics laboratories | ANTIBODY TO RUBELLA VIRUS | March 19, 1980 |
| K792133 | microbiological assoc | RUBELISA TEST KIT | January 11, 1980 |
| K790122 | organon | RUBANON | February 15, 1979 |
| K781638 | ortho diagnostics | RUBINDEX*DIRECT SYSTEM | December 20, 1978 |
| K781392 | microbiological assoc | CYTOMEGILISH TEST KIT | October 24, 1978 |
| K780010 | northeast biomedical labs | GOAT ANTI-RUBELLA ANTISERA | January 20, 1978 |
| K780063 | organon | RUBENOSTICON | January 20, 1978 |
| K771956 | flow laboratories | HUMAN O BUFFER | October 28, 1977 |
| K771957 | flow laboratories | RUBELLA HEMAGGLUTINATION REAGENT KIT | October 28, 1977 |