The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Dimension C-reactive Protein Method.
| Device ID | K945280 |
| 510k Number | K945280 |
| Device Name: | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1995-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005527 | K945280 | 000 |