Kit, Identification, Mycobacteria
FDA product code JSY · Class I (low risk) · 21 CFR 866.2660 · Microbiology
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943051 | Mycoakt M. Tuberculosis Cuulture Id KitJSY · Traditional | Dynagen, Inc. | 03/13/1995SE |
| K943050 | Mycoakt M Kansasii Culture Id KitJSY · Traditional | Dynagen, Inc. | 03/13/1995SE |
| K943049 | Mycoakt M. Avium Culture Id KitJSY · Traditional | Dynagen, Inc. | 03/13/1995SE |
| K880990 | Ats 0.2% Bovine Albumin Fraction V SolutionJSY · Traditional | Alpha-Tec Systems, Inc. | 03/24/1988SE |
| K830211 | Api Tb-Ident*JSY · Traditional | Analytical Products, Inc. | 03/24/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1733-2009 | Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the…The plate labeling is incorrect, but the outer box labeling is correct | Remel, Inc | 05/06/2009Terminated |