The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Creatinine Color Reagent 2310 &.
| Device ID | K853888 |
| 510k Number | K853888 |
| Device Name: | AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| 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 | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-19 |
| Decision Date | 1985-10-15 |