JRE · Class I · 21 CFR 862.2800

FDA Product Code JRE: Refractometer For Clinical Use

Leading manufacturers include Vee Gee Scientific, Inc., Gyrus Medical , Ltd. and Teco Diagnostics.

13
Total
13
Cleared
185d
Avg days
1979
Since

FDA 510(k) Cleared Refractometer For Clinical Use Devices (Product Code JRE)

13 devices
1–13 of 13
Cleared Mar 11, 1996
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
K954977
Teco Diagnostics
Chemistry · 147d
Cleared Jan 17, 1995
MODEL 2721 CLINICAL REFRACTOMETER
K941901
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
MODEL 2740 CLINICAL REFRACTOMETER
K941903
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
MODEL 2730 CLINICAL REFRACTOMETER
K941906
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Dec 13, 1994
MODEL 3471 CLINICAL REFRACTOMETER
K941902
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
MODEL A300CL CLINICAL REFRACTOMETER
K941904
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
MODEL 3461 CLINICAL REFRACTOMETER
K941905
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared May 01, 1990
DILECTRON URINARY CONDUCTIVITY PROBE
K891681
Gyrus Medical , Ltd.
Chemistry · 405d
Cleared Jul 16, 1984
ATAGO URINE SPECIFIC GRAVITY & SERUM
K842168
Kyoto Diagnostics, Inc.
Chemistry · 46d
Cleared Jun 30, 1983
SPECIFIC GRAVITY INSTRUMENT
K831213
Iris
Chemistry · 77d
Cleared Sep 01, 1981
REAGENT STRIPS FOR URINALYSIS
K811342
Miles Laboratories, Inc.
Chemistry · 112d
Cleared Jun 28, 1979
BIOVATION DIGITAL URINOMETER
K790862
Biovation, Inc.
Chemistry · 52d

About Product Code JRE - Regulatory Context