510(k) K052301 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
FASTPACK TSH IMMUNOASSAY
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 4, 2006 |
| Received | Aug 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052301
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2024 | Qualigen Inc FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer Open, Classified |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.