510(k) K003094 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 25, 2000 |
| Received | Oct 3, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003094
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.