510(k) K972333 ยท JIX Calibrator, Multi-Analyte Mixture
AMMONIA/IRON STANDARD KIT
| Applicant | Verichem Laboratories, Inc., Providence RI, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | Jun 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972333
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2007 | Mega Diagnostics Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials Terminated |
JIX | None listed |
| Sep 30, 2006 | Pointe Scientific, Inc. Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL. Terminated |
JIX | None listed |
| Sep 30, 2006 | Pointe Scientific, Inc. Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL. Terminated |
JIX | None listed |
| Sep 30, 2006 | Pointe Scientific, Inc. Alcohol Control, Level 1 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L1. Terminated |
JIX | None listed |
| Sep 30, 2006 | Pointe Scientific, Inc. Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2. Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.