510(k) K831643 ยท LIB Device, General Purpose, Microbiology, Diagnostic
STRIPREADER MICROELISA SYSTEM
| Applicant | Organon Teknika Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 26, 1983 |
| Received | May 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831643
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.