The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Creatinine Meth For Use On The Dimension Clin Chem.
| Device ID | K925668 |
| 510k Number | K925668 |
| Device Name: | CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-10 |
| Decision Date | 1992-12-28 |