The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Kinase Isoenzyme.
| Device ID | K943024 |
| 510k Number | K943024 |
| Device Name: | KINASE ISOENZYME |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022 BMP 22/1158 Wilmington, DE 19880 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DUPONT MEDICAL PRODUCTS P.O. BOX 80022 BMP 22/1158 Wilmington, DE 19880 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-26 |
| Decision Date | 1994-08-02 |