510(k) K873064 ยท DHR System, Test, Rheumatoid Factor
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
| Applicant | Amtec Diagnostics International, Inc., Conroe TX, US |
| Decision | Substantially Equivalent, Nov 4, 1987 |
| Received | Aug 5, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873064
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.