Panels › Microbiology › Product code GTP · Class 1
Exoenzymes, Multiple, Streptococcal
Regulation 866.3720
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GTP
| Company | 510(k)s | Recalls |
|---|---|---|
| American Scientific Products | 1 | 0 |
| Bio Spec, Inc. | 1 | 0 |
| Cooper Biomedical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 1986 | K860041 | STREP D FLUOR Bio Spec, Inc. | GTP |
| Dec 27, 1983 | K833738 | LEAP STREP TEST KIT Cooper Biomedical, Inc. | GTP |
| Dec 19, 1982 | K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT American Scientific Products | GTP |
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