510(k) K002121 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
TOTAL PSA MICROTITER ELISA
| Applicant | Oncogene Science, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Aug 30, 2000 |
| Received | Jul 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002121
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.