FDA 510(k) Applications for Medical Device Product Code "CKB"
(Acid Phosphatase, Naphthyl Phosphate)

FDA 510(k) Number Applicant Device Name Decision Date
K991010 ABBOTT DIAGNOSTICS MFG., INC. ACP 05/19/1999
K840661 AMERICAN DADE PARAMAX ACID PHOSPHATASE REAGENT 04/04/1984
K023840 BAYER DIAGNOSTICS CORP. ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 01/07/2003
K053612 BECKMAN COULTER, INC. DRI-STAT ACID PHOSPHATASE REAGENT 04/26/2006
K823087 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA 11/18/1982
K853949 COOPER BIOMEDICAL, INC. DEMAND ACID PHOSPHATASE REAGENT 10/16/1985
K902543 CRESTAT DIAGNOSTICS, INC. ACID PHOSPHOTASE REAGENT TEST AND KIT 09/07/1990
K861675 DATA MEDICAL ASSOCIATES, INC. ACID PHOSPHATASE PROCEDURE 05/29/1986
K850902 DATA MEDICAL ASSOCIATES, INC. DATA ZYME ACID PHOSPHATASE PROCEDURE 03/20/1985
K875209 DIAGNOSTIC CHEMICALS, LTD. (USA) ACID PHOSPHATASE (KINETIC) CAT. # 320-06 02/01/1988
K820975 GILFORD DIAGNOSTICS GILCHEM ACID PHOSPHATASE REAGENT 04/26/1982
K943366 INSTRUMENTATION LABORATORY CO. IL TEST ACID PHOSPHATASE 01/29/1996
K854223 MARVIC INTERPHARMA, INC. VES-TEC/VES-MATIC 04/04/1986
K892393 MEDICAL ANALYSIS SYSTEMS, INC. ACID PHOSPHATASE REAGENT 07/20/1989
K963640 OLYMPUS AMERICA, INC. OLYMPUS ACID PHOSPHATASE REAGENT 02/18/1997
K981743 OLYMPUS AMERICA, INC. OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER 06/09/1998
K831834 REAGENTS APPLICATIONS, INC. RAICHEM ACID PHASPHATASE REAGENT 08/26/1983
K974695 ROCHE DIAGNOSTIC SYSTEMS, INC. COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) 05/21/1998
K881204 SCLAVO, INC. ACP KINETIC TEST (ACID PHOSPHATASE TEST) 04/28/1988
K863851 SIGMA DIAGNOSTICS, INC. ACID PHOSPHATASE (ACP) REAGENT 10/16/1986
K821674 SMITH KLINE DIAGNOSTICS, INC. SPINCHEM ACID PHOSPHATASE REAGENT 06/22/1982
K902495 TECH INTL. CO. ACID PHOSPHATASE REAGENT SET 07/16/1990
K884747 TECHNICON INSTRUMENTS CORP. TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) 01/30/1989
K880798 TRACE AMERICA, INC. ACID PHOSPHATASE REAGENT 04/18/1988


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