The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Creatine Kinase (ck) Reagent Set.
| Device ID | K930660 |
| 510k Number | K930660 |
| Device Name: | CREATINE KINASE (CK) REAGENT SET |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-09 |
| Decision Date | 1993-03-29 |