510(k) K981634 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
| Applicant | Biocircuits Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 13, 1998 |
| Received | May 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981634
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.