JRE · Class I · 21 CFR 862.2800

FDA Product Code JRE: Refractometer For Clinical Use

Leading manufacturers include Miles Laboratories, Inc. 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 Sep 01, 1981
REAGENT STRIPS FOR URINALYSIS
K811342
Miles Laboratories, Inc.
Chemistry · 112d

About Product Code JRE - Regulatory Context