The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Amresco Flow Pac Total Bilirubin Reagents.
| Device ID | K862299 |
| 510k Number | K862299 |
| Device Name: | AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Timothy J Belcastro |
| Correspondent | Timothy J Belcastro AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. 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 | 1986-06-17 |
| Decision Date | 1986-07-01 |