Panels › Microbiology › Product code JSY · Class 1
Kit, Identification, Mycobacteria
Regulation 866.2660
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in JSY
| Company | 510(k)s | Recalls |
|---|---|---|
| Dynagen, Inc. | 3 | 0 |
| Alpha-Tec Systems, Inc. | 1 | 0 |
| Analytical Products, Inc. | 1 | 0 |
| Remel, Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 1995 | K943051 | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT Dynagen, Inc. | JSY |
| Mar 13, 1995 | K943050 | MYCOAKT M KANSASII CULTURE ID KIT Dynagen, Inc. | JSY |
| Mar 13, 1995 | K943049 | MYCOAKT M. AVIUM CULTURE ID KIT Dynagen, Inc. | JSY |
| Mar 24, 1988 | K880990 | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION Alpha-Tec Systems, Inc. | JSY |
| Mar 24, 1983 | K830211 | API TB-IDENT* Analytical Products, Inc. | JSY |
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