K935662 is an FDA 510(k) clearance for the SYNERMED IR 500 CHEMISTRY ANALYZER. This device is classified as a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I - General Controls, product code JIQ).
Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on April 26, 1994, 151 days after receiving the submission on November 26, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K935662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1993 |
| Decision Date | April 26, 1994 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIQ — Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1645 |