510(k) K101390 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
FASTPACK TSH IMMUNOASSAY
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 13, 2010 |
| Received | May 17, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101390
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.