The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Standard C For The Dimension Clinical Chemistry System.
| Device ID | K933955 |
| 510k Number | K933955 |
| Device Name: | DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170 Wilmington, DE 19880 -0022 |
| Contact | Carolyn Kruer George |
| Correspondent | Carolyn Kruer George E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170 Wilmington, DE 19880 -0022 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-12 |
| Decision Date | 1993-10-13 |