The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Creatine Kinase For Manual/automated Applications.
| Device ID | K894715 |
| 510k Number | K894715 |
| Device Name: | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-25 |
| Decision Date | 1989-11-08 |