The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ck.
| Device ID | K983070 |
| 510k Number | K983070 |
| Device Name: | CK |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1999-02-16 |
| Summary: | summary |