The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Near-infrared Direct Bilirubin Reagent Kit.
| Device ID | K973109 |
| 510k Number | K973109 |
| Device Name: | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, 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 | 1997-08-19 |
| Decision Date | 1997-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091811 | K973109 | 000 |
| 05060500090333 | K973109 | 000 |
| 05060500090326 | K973109 | 000 |
| 05060500090319 | K973109 | 000 |
| 05060500090302 | K973109 | 000 |
| 05060500090296 | K973109 | 000 |