510(k) K101388 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
FASTPACK TESTO IMMUNOASSAY
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 18, 2011 |
| Received | May 17, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101388
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.