CDH · Class I · 21 CFR 862.1775

FDA Product Code CDH: Acid, Uric, Phosphotungstate Reduction

Leading manufacturers include Volu Sol Medical Industries, Stanbio Laboratory and Diagnostic Solutions, Inc..

15
Total
15
Cleared
45d
Avg days
1976
Since

FDA 510(k) Cleared Acid, Uric, Phosphotungstate Reduction Devices (Product Code CDH)

15 devices
1–15 of 15
Cleared May 01, 1984
URIC ACID REAGENT SET
K841067
Medical Specialties, Inc.
Chemistry · 50d
Cleared Jul 13, 1982
URIC ACID REAGENT SET
K821213
Omega Medical Electronics
Chemistry · 77d
Cleared Nov 16, 1981
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076
American Monitor Corp.
Chemistry · 14d
Cleared Jan 28, 1981
URIC ACID (TPTZ) COLORINMETRIC
K810088
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
K800672
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Feb 13, 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190
Stanbio Laboratory
Chemistry · 15d
Cleared Dec 07, 1979
ELVI URIC ACID-COLORIMETRIC METHOD
K792403
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID
K792412
Volu Sol Medical Industries
Chemistry · 11d
Cleared Feb 26, 1979
SERUM, URIC ACID DETERMINATION
K790019
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Nov 28, 1977
ENZAC URIC ACID 100-TEST KIT
K772082
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 25d
Cleared Oct 25, 1977
URIC ACID
K771842
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Jun 03, 1977
URIC ACID TEST KIT
K770564
Mallinckrodt Critical Care
Chemistry · 71d
Cleared Apr 29, 1977
URIC ACID PROCEDURE, TEKPOINT DIRECT
K770459
Icn Pharmaceuticals, Inc.
Chemistry · 52d

About Product Code CDH - Regulatory Context