The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Product Number 7728 (bilirubin Dpd).
Device ID | K900571 |
510k Number | K900571 |
Device Name: | AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) |
Classification | Diazo Colorimetry, Bilirubin |
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 | CIG |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-07 |
Decision Date | 1990-04-16 |