510(k) K030329 ยท CEC Radioimmunoassay, Free Thyroxine
FASTPACK FREE T4 IMMUNOASSAY
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 3, 2003 |
| Received | Jan 31, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2013 | Qualigen Inc FastPack Free T4 Immunoassay
Chemilunescence assay for the determination of Free T4
The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determinati Terminated |
CEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.