510(k) K974816 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 20, 1998 |
| Received | Dec 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974816
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.