The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Creatine Kinase-mb Reagent.
| Device ID | K913398 |
| 510k Number | K913398 |
| Device Name: | RAICHEM(TM) CREATINE KINASE-MB REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Alfred E Peacock |
| Correspondent | Alfred E Peacock REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-30 |
| Decision Date | 1991-09-25 |