510(k) K983070 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CK
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Feb 16, 1999 |
| Received | Sep 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2018 | Abbott Laboratories, Inc Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. Terminated |
CGS | None listed |
| Jul 18, 2018 | Abbott Laboratories, Inc Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. Terminated |
CGS | None listed |
| Mar 19, 2008 | Abbott Laboratories Inc. Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030 Terminated |
CGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.