510(k) K881501 ยท JSX Kit, Identification, Neisseria Gonorrhoeae
MODIFIED IDS RAPID NH SYSTEM
| Applicant | Innovative Diagnostic Systems, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, May 18, 1988 |
| Received | Apr 11, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881501
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.