Cleared Traditional

K941903 - MODEL 2740 CLINICAL REFRACTOMETER
(FDA 510(k) Clearance)

Jan 1995
Decision
273d
Days
Class 1
Risk

K941903 is an FDA 510(k) clearance for the MODEL 2740 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 January 17, 1995, 273 days after receiving the submission on April 19, 1994.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2800.

Submission Details

510(k) Number K941903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1994
Decision Date January 17, 1995
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JRE — Refractometer For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2800

Similar Devices — JRE Refractometer For Clinical Use

All 12
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
K954977 · Teco Diagnostics · Mar 1996
MODEL 2721 CLINICAL REFRACTOMETER
K941901 · Vee Gee Scientific, Inc. · Jan 1995
MODEL 2730 CLINICAL REFRACTOMETER
K941906 · Vee Gee Scientific, Inc. · Jan 1995
MODEL 3471 CLINICAL REFRACTOMETER
K941902 · Vee Gee Scientific, Inc. · Dec 1994
MODEL A300CL CLINICAL REFRACTOMETER
K941904 · Vee Gee Scientific, Inc. · Dec 1994
MODEL 3461 CLINICAL REFRACTOMETER
K941905 · Vee Gee Scientific, Inc. · Dec 1994