510(k) K991432 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
| Applicant | Biocheck, Inc., Northridge CA, US |
| Decision | Substantially Equivalent, Jun 2, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2021 | BioCheck, Inc. T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only
This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. T Terminated |
KLI | None listed |
| Oct 18, 2021 | DRG International, Inc. Total Thyroxine (T4) ELISA; REF EIA-1781 Open, Classified |
KLI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.