K941905 is an FDA 510(k) clearance for the MODEL 3461 CLINICAL REFRACTOMETER. This device is classified as a Refractometer For Clinical Use (Class I - General Controls, product code JRE).
Submitted by Vee Gee Scientific, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 13, 1994, 238 days after receiving the submission on April 19, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2800.
| 510(k) Number | K941905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1994 |
| Decision Date | December 13, 1994 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JRE — Refractometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2800 |