510(k) K943051 ยท JSY Kit, Identification, Mycobacteria
MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
| Applicant | Dynagen, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 13, 1995 |
| Received | Jun 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943051
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.