FDA 510(k) Applications for Medical Device Product Code "CDH"
(Acid, Uric, Phosphotungstate Reduction)

FDA 510(k) Number Applicant Device Name Decision Date
K813076 AMERICAN MONITOR CORP. PHOSPHOTUNGSTATE REDUCTION, URIC ACID 11/16/1981
K772082 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ENZAC URIC ACID 100-TEST KIT 11/28/1977
K810088 BIO-ANALYTICS LABORATORIES, INC. URIC ACID (TPTZ) COLORINMETRIC 01/28/1981
K800672 DIAGNOSTIC SOLUTIONS, INC. SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC 05/28/1980
K850933 DILAB, INC. URIC ACID 06/25/1985
K790019 FISHER SCIENTIFIC CO., LLC. SERUM, URIC ACID DETERMINATION 02/26/1979
K771842 GAMMA ENTERPRISES, INC. URIC ACID 10/25/1977
K770459 ICN PHARMACEUTICALS, INC. URIC ACID PROCEDURE, TEKPOINT DIRECT 04/29/1977
K770564 MALLINCKRODT CRITICAL CARE URIC ACID TEST KIT 06/03/1977
K841067 MEDICAL SPECIALTIES, INC. URIC ACID REAGENT SET 05/01/1984
K821213 OMEGA MEDICAL ELECTRONICS URIC ACID REAGENT SET 07/13/1982
K760477 SIMMLER & SON, INC. REAGENTS-4 FOR URIC ACID DETERMINATION 10/29/1976
K800190 STANBIO LABORATORY STANBIO DIRECT URIC ACID TEST SET #0770 02/13/1980
K792412 VOLU SOL MEDICAL INDUSTRIES ELVI URIC ACID 12/07/1979
K792403 VOLU SOL MEDICAL INDUSTRIES ELVI URIC ACID-COLORIMETRIC METHOD 12/07/1979


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact