The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Biuret (colormetric), Total Protein.
| Device ID | K901527 |
| 510k Number | K901527 |
| Device Name: | BIURET (COLORMETRIC), TOTAL PROTEIN |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Patel, Phd |
| Correspondent | Patel, Phd AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-02 |
| Decision Date | 1990-07-19 |