GOL — Antigen, Ha (Including Ha Control), Rubella Class II
FDA product code GOL covers "Antigen, Ha (Including Ha Control), Rubella", a Class II medical device regulated under 21 CFR 866.3510. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GOL
- 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 |
|---|---|---|---|
| K841174 | intl. diagnostic technology | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | June 7, 1984 |
| K834032 | abbott laboratories | RUBAQUICK DIAGNOSTIC KIT | April 17, 1984 |
| K810309 | calbiochem-behring | RUBELLA ANTIBODIES TEST REAGENTS | March 11, 1981 |
| K802102 | calbiochem-behring | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | December 18, 1980 |
| K802339 | beckman instruments | EIA RUBELLA-G | December 18, 1980 |
| K802508 | m.a. bioproducts | RUBELISA IGM TEST KIT | December 18, 1980 |
| K801667 | clinical assays | GAMMA COAT(125 I) RUBELLA ANTIBODY | October 23, 1980 |
| K801098 | flow laboratories | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | September 16, 1980 |
| K801507 | ortho diagnostics | ANTIGEN CONTROL CELLS | August 20, 1980 |
| K800789 | litton bionetics | RUBELLA BIO-BEAD TITRATION KIT | June 30, 1980 |
| K800797 | bd becton dickinson vacutainer systems preanalytic | MACRO-VUE RUBELLA CARD TEST | June 20, 1980 |
| K792249 | intl. diagnostic technology | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | January 23, 1980 |
| K791610 | litton bionetics | RUBELLA BIO-BEAD SCREEN KIT | November 13, 1979 |
| K790976 | abbott laboratories | RUBAZYME | August 16, 1979 |
| K790212 | cordis | CORDIA T | April 12, 1979 |
| K780885 | cordis | CORDIA R | January 17, 1979 |
| K771796 | behring diagnostics | RUBA-NOST TEST KITS | October 18, 1977 |
| K770805 | flow laboratories | MEASLES-FA LABELLED (8-441 RF) | May 20, 1977 |
| K770809 | flow laboratories | MEASLES-FA LABELED PRESERUM (8-441 RNF) | May 20, 1977 |
| K770092 | microbiological research | HERPESIVIRUS TEST (TYPE L & 2) | March 1, 1977 |