The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Creatinine Reagents Product #7790, 7791.
| Device ID | K900666 |
| 510k Number | K900666 |
| Device Name: | AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Owens |
| Correspondent | Owens AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-04-19 |