The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Creatinine Reagent #4316100.
Device ID | K896686 |
510k Number | K896686 |
Device Name: | AMRESCO CREATININE REAGENT #4316100 |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Contact | C. K Owens |
Correspondent | C. K 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 | 1989-11-28 |
Decision Date | 1990-02-08 |