ClearanceBrief
Panels › Clinical Chemistry › Product code CDH · Class 1

Acid, Uric, Phosphotungstate Reduction

Regulation 862.1775

0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in CDH

Company510(k)sRecalls
Volu Sol Medical Industries20
American Monitor Corp.10
Bd Becton Dickinson Vacutainer Systems Preanalytic10
Bio-Analytics Laboratories, Inc.10
Diagnostic Solutions, Inc.10
Dilab, Inc.10
Fisher Scientific Co., LLC10
Gamma Enterprises, Inc.10
Icn Pharmaceuticals, Inc.10
Mallinckrodt Critical Care10
Decided510(k)Device and applicantCode
Jun 25, 1985K850933URIC ACID
Dilab, Inc.
CDH
May 1, 1984K841067URIC ACID REAGENT SET
Medical Specialties, Inc.
CDH
Jul 13, 1982K821213URIC ACID REAGENT SET
Omega Medical Electronics
CDH
Nov 16, 1981K813076PHOSPHOTUNGSTATE REDUCTION, URIC ACID
American Monitor Corp.
CDH
Jan 28, 1981K810088URIC ACID (TPTZ) COLORINMETRIC
Bio-Analytics Laboratories, Inc.
CDH
May 28, 1980K800672SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
Diagnostic Solutions, Inc.
CDH
Feb 13, 1980K800190STANBIO DIRECT URIC ACID TEST SET #0770
Stanbio Laboratory
CDH
Dec 7, 1979K792412ELVI URIC ACID
Volu Sol Medical Industries
CDH
Dec 7, 1979K792403ELVI URIC ACID-COLORIMETRIC METHOD
Volu Sol Medical Industries
CDH
Feb 26, 1979K790019SERUM, URIC ACID DETERMINATION
Fisher Scientific Co., LLC
CDH
Nov 28, 1977K772082ENZAC URIC ACID 100-TEST KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDH
Oct 25, 1977K771842URIC ACID
Gamma Enterprises, Inc.
CDH
Jun 3, 1977K770564URIC ACID TEST KIT
Mallinckrodt Critical Care
CDH
Apr 29, 1977K770459URIC ACID PROCEDURE, TEKPOINT DIRECT
Icn Pharmaceuticals, Inc.
CDH
Oct 29, 1976K760477REAGENTS-4 FOR URIC ACID DETERMINATION
Simmler & Son, Inc.
CDH

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