The following data is part of a premarket notification filed by Cooperbiomedical, Inc. with the FDA for Demand Total Protein.
| Device ID | K863301 |
| 510k Number | K863301 |
| Device Name: | DEMAND TOTAL PROTEIN |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | COOPERBIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Brewster, Phd |
| Correspondent | Brewster, Phd COOPERBIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-25 |
| Decision Date | 1986-09-26 |