510(k) K990658 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
| Applicant | Little Nell Labs, Inc., Basalt CO, US |
| Decision | Substantially Equivalent, Jun 2, 1999 |
| Received | Mar 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990658
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.