K953395 is an FDA 510(k) clearance for the SYNERMED CALCIUM REAGENT KIT. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on August 31, 1995, 44 days after receiving the submission on July 18, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K953395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1995 |
| Decision Date | August 31, 1995 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CJY — Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |