The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Direct Bilirubin Reagent, 7776/7777/7576/7476/7176.
| Device ID | K904468 |
| 510k Number | K904468 |
| Device Name: | DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Patel, Ph.d. |
| Correspondent | Patel, Ph.d. AMRESCO, INC. 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 | 1990-10-01 |
| Decision Date | 1991-01-17 |