510(k) K894159 ยท KHO Fluorometer, For Clinical Use
OPUS IMMUNOASSAY SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Aug 3, 1989 |
| Received | Jun 14, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894159
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.