The following data is part of a premarket notification filed by Ac Biochemicals, Inc. with the FDA for Creatine Kinase Reagent.
| Device ID | K980012 |
| 510k Number | K980012 |
| Device Name: | CREATINE KINASE REAGENT |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J Irvine, CA 92614 |
| Contact | Charles C Allain |
| Correspondent | Charles C Allain AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J Irvine, CA 92614 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-02 |
| Decision Date | 1998-02-25 |