The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Total Bilirubin Reagent 1372,1425,1284,1273,053583.
| Device ID | K871530 |
| 510k Number | K871530 |
| Device Name: | TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Jan Brownlee |
| Correspondent | Jan Brownlee 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 | 1987-04-20 |
| Decision Date | 1987-05-14 |