The following data is part of a premarket notification filed by Synermed Intl., Inc. with the FDA for Synermed Near-infrared Direct Bilirubin Reagent Kit.
| Device ID | K983304 |
| 510k Number | K983304 |
| Device Name: | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SYNERMED INTL., INC. 1688 50TH AVE. Lachine, Quebec, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED INTL., INC. 1688 50TH AVE. Lachine, Quebec, CA H8t 2v5 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1998-11-04 |