ANTIBODY TO RUBELLA VIRUS
FDA 510(k) clearance K792635 · decided 1980-03-19
Clearance details
- K-number
- K792635
- Device name
- ANTIBODY TO RUBELLA VIRUS
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-19
- Decision date
- 1980-03-19
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- GOK
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.