510(k) K915870 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
OPUS RUBELLA TEST SYSTEM
| Applicant | Pb Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Mar 23, 1992 |
| Received | Dec 31, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915870
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.