The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Ck (creatine Kinase) Reagent.
| Device ID | K901267 |
| 510k Number | K901267 |
| Device Name: | COULTER CK (CREATINE KINASE) REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | A Richardson-jones |
| Correspondent | A Richardson-jones COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-16 |
| Decision Date | 1990-05-23 |