GOK
11 FDA 510(k) clearances · Product code
41 daysmedian time to decision
90 days90th percentile
11clearances measured
FDA profile
- Official device name
- Antisera, Hai (Including Hai Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RUBASCAN LATEX CARD TEST (K832228) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-29 |
| RUBAZYME - M (K810835) | Abbott Laboratories | 1981-05-05 |
| ANTIBODY TO RUBELLA VIRUS (K792635) | Electro-Nucleonics Laboratories, Inc. | 1980-03-19 |
| RUBELISA TEST KIT (K792133) | Microbiological Assoc. | 1980-01-11 |
| RUBANON (K790122) | Organon, Inc. | 1979-02-15 |
| RUBINDEX*DIRECT SYSTEM (K781638) | Ortho Diagnostics, Inc. | 1978-12-20 |
| CYTOMEGILISH TEST KIT (K781392) | Microbiological Assoc. | 1978-10-24 |
| GOAT ANTI-RUBELLA ANTISERA (K780010) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| RUBENOSTICON (K780063) | Organon, Inc. | 1978-01-20 |
| HUMAN O BUFFER (K771956) | Flow Laboratories, Inc. | 1977-10-28 |
| RUBELLA HEMAGGLUTINATION REAGENT KIT (K771957) | Flow Laboratories, Inc. | 1977-10-28 |
Track GOK automatically
Every clearance here is in the API, with alerts when new ones post.