The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Dimension Total Protein Method.
| Device ID | K950920 |
| 510k Number | K950920 |
| Device Name: | DUPONT DIMENSION TOTAL PROTEIN METHOD |
| Classification | Biuret (colorimetric), Total Protein |
| 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 | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-01 |
| Decision Date | 1995-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005671 | K950920 | 000 |