510(k) K994419 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
| Applicant | Qualisys Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 28, 2000 |
| Received | Dec 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2013 | Qualigen Inc FastPack Total PSA Immunoassay
Chemilunescence assay for the determination of Total PSA.
FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determina Terminated |
LTJ | None listed |
| Dec 22, 2008 | Qualigen Inc FastPack(R) Total PSA Immunoassay; Catalog #: 25000001
Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma Terminated |
LTJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.