The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Total Protein Procedure.
| Device ID | K832169 |
| 510k Number | K832169 |
| Device Name: | TOTAL PROTEIN PROCEDURE |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | SANDARE CHEMICAL CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-06 |
| Decision Date | 1983-08-16 |