Submission Details
| 510(k) Number | K903103 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1990 |
| Decision Date | August 09, 1990 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K903103 is an FDA 510(k) clearance for the SYNERMED CHLORIDE REAGENT KIT, a Acid, Phosphoric-tungstic (spectrophotometric), Chloride (Class II — Special Controls, product code CHG), submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on August 9, 1990, 27 days after receiving the submission on July 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K903103 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1990 |
| Decision Date | August 09, 1990 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHG — Acid, Phosphoric-tungstic (spectrophotometric), Chloride |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1170 |