The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Total Protein Biuret & Blank Conc.
| Device ID | K852844 |
| 510k Number | K852844 |
| Device Name: | AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. P.O. BOX 21009 South Euclid, OH 44121 |
| Contact | Timothy J Belcastro |
| Correspondent | Timothy J Belcastro AMERICAN RESEARCH PRODUCTS CO. P.O. BOX 21009 South Euclid, OH 44121 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-05 |
| Decision Date | 1985-07-22 |