FDA 510(k) Applications for Medical Device Product Code "CED"
(5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase)

FDA 510(k) Number Applicant Device Name Decision Date
K820832 AMERICAN MONITOR CORP. PHOSPHORUS IL 04/15/1982
K833710 BTC DIAGNOSTICS, INC. BTC URINE LH ASSAY 01/30/1984
K811222 CONNECTICUT DIAGNOSTICS, LTD. INORGANIC PHOSPHORUS REAGENTS 05/21/1981
K840151 EASTMAN KODAK COMPANY EKTACHEM CLINICAL CHEM. SLIDES 03/22/1984
K894288 EM DIAGNOSTIC SYSTEMS, INC. PHOSPHORUS TEST ITEM NUMBER 65416 08/31/1989
K812670 SANDARE CHEMICAL CO., INC. SANDARE FAST 340 PHOSPHORUS PROCEDURE 10/02/1981
K811864 SIGMA CHEMICAL CO. SIGMA PROCEDURE 265-UV 07/31/1981
K790662 UNION CARBIDE CORP. CENTRIFICHEM INORGANIC PHOSPHORUS 05/15/1979
K802420 UNION CARBIDE CORP. CENTRIFICHEM INORGANIC PHOSPHORUS 10/31/1980


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