K973109 is an FDA 510(k) clearance for the SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on September 25, 1997, 37 days after receiving the submission on August 19, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K973109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1997 |
| Decision Date | September 25, 1997 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |