GOKClass II
Antisera, Hai (including Hai Control), Rubella
Microbiology · 21 CFR 866.3510
MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances11All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
11 clearances for this product code
- Bd Becton Dickinson Vacutainer Systems PreanalyticSep 29, 1983
K832228 · RUBASCAN LATEX CARD TEST
- Abbott LaboratoriesMay 5, 1981
K810835 · RUBAZYME - M
- Electro-Nucleonics Laboratories, Inc.Mar 19, 1980
K792635 · ANTIBODY TO RUBELLA VIRUS
- Microbiological Assoc.Jan 11, 1980
K792133 · RUBELISA TEST KIT
- Organon, Inc.Feb 15, 1979
K790122 · RUBANON
- Ortho Diagnostics, Inc.Dec 20, 1978
K781638 · RUBINDEX*DIRECT SYSTEM
- Microbiological Assoc.Oct 24, 1978
K781392 · CYTOMEGILISH TEST KIT
- Northeast Biomedical Labs., Inc.Jan 20, 1978
K780010 · GOAT ANTI-RUBELLA ANTISERA