510(k) K981799 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
CREA
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jul 22, 1998 |
| Received | May 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20 Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.