510(k) K123983 ยท MRG System, Test, Vitamin D
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 3, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2017 | Qualigen Inc Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068
Vitamin D immunoassay kit Terminated |
MRG | None listed |
| Dec 19, 2013 | Qualigen Inc FastPack Free T4 Immunoassay
FastPack Vitamin D Immunoassay
Chemilunescence assay for the determination of Vitamin D
The FastPack Vitamin D Immunoassay is intended for the quantitative determinatio Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.