510(k) K880990 ยท JSY Kit, Identification, Mycobacteria
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION
| Applicant | Alpha-Tec Systems, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 24, 1988 |
| Received | Mar 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880990
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.