510(k) K994200 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACCESS HYBRITECH PSA QC, MODEL 37209
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Dec 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994200
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.