JJB · Class I · 21 CFR 862.1115

FDA Product Code JJB: Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)

Leading manufacturers include Syn-Kit, Inc., Wako Chemicals USA, Inc. and Teco Diagnostics.

5
Total
5
Cleared
115d
Avg days
1984
Since

FDA 510(k) Cleared Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) Devices (Product Code JJB)

5 devices
1–5 of 5
Cleared Apr 24, 1995
URINE REAGENT STRIPS-8 PARAMETERS
K943436
Teco Diagnostics
Chemistry · 280d
Cleared Sep 22, 1987
WAKO(TM) PRETEST 8A
K873553
Wako Chemicals USA, Inc.
Chemistry · 25d
Cleared Jan 11, 1984
REAGENT TESTS STRIP COMBINATIONS
K833521
Syn-Kit, Inc.
Chemistry · 92d

About Product Code JJB - Regulatory Context