510(k) K971777 ยท JJT Enzyme Controls (Assayed And Unassayed)
QUANTEX ASO-CRP-RF CONTROL
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, May 27, 1997 |
| Received | May 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971777
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.