The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Creatine Kinase Method.
| Device ID | K941584 |
| 510k Number | K941584 |
| Device Name: | CREATINE KINASE METHOD |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-07-06 |