510(k) K971602 ยท DHR System, Test, Rheumatoid Factor
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971602
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.