510(k) K965100 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
| Applicant | Crestat Diagnostics, Inc., Weston CT, US |
| Decision | Substantially Equivalent, Jul 14, 1997 |
| Received | Dec 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Zimmer, Inc. M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.