FDA 510(k) Applications for Medical Device Product Code "CIJ"
(Saccharogenic, Amylase)

FDA 510(k) Number Applicant Device Name Decision Date
K980013 AC BIOCHEMICALS, INC. AMYLASE 02/04/1998
K813529 AMERICAN DADE DADE COLORIMETRIC AMYLASE 12/31/1981
K991817 BAYER CORP. ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM 07/22/1999
K760415 BECKMAN INSTRUMENTS, INC. ENZYMATIC AMYLASE REAGENT KIT 11/05/1976
K871943 BEHRING DIAGNOSTICS, INC. D.A.T. (TM) AMYLASE REAGENT 06/03/1987
K853951 BEHRING DIAGNOSTICS, INC. ISOTRAK AMYLASE TEST AMYLASE ISOENZYME 01/07/1986
K872831 BIOTROL, USA, INC. BIOTROL ALPHA AMYLASE 09/04/1987
K931141 BIOTROL, USA, INC. BIOTROL AMYLASE CNPG3 05/26/1993
K882225 BOEHRINGER MANNHEIM CORP. -AMYLASE EPS 01/03/1989
K834053 COULTER ELECTRONICS, INC. DART ALPHA-AMYLASE REAGENT SYSTEM 02/04/1984
K862370 COULTER ELECTRONICS, INC. DART AMYLASE-D.S. REAGENT SYSTEM 08/01/1986
K861664 DATA MEDICAL ASSOCIATES, INC. AMYLASE PROCEDURE 07/01/1986
K940010 DATA MEDICAL ASSOCIATES, INC. DMA AMYLASE (DEMAND) PROCEDURE 03/11/1994
K852636 DIAGNOSTIC CHEMICALS, LTD. (USA) X-AMYLASE ASSAY KIT 07/12/1985
K860935 EM DIAGNOSTIC SYSTEMS, INC. EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 05/23/1986
K843645 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE A AMYLASE HEM 67204 09/28/1984
K951494 EMD CHEMICALS INC. AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) 12/11/1995
K792479 GENERAL DIAGNOSTICS CHEM-STRATE AMYLASE 12/27/1979
K812594 HARLECO ULTRA ZYME PLUS AMYL #64982 & 65031 10/02/1981
K780513 HARLECO ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 05/19/1978
K760026 HARLECO ULTRAZYME AMYLASE 09/21/1976
K780141 HARLECO ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. 03/09/1978
K873572 INSTRUMENTATION LABORATORY CO. IL 35260, IL TEST AMYLASE REAGENT 10/20/1987
K931301 OLYMPUS CORP. OLYMPUS AMYLASE REAGENT 10/18/1993
K023396 POINTE SCIENTIFIC, INC. AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) 12/23/2002
K940735 POINTE SCIENTIFIC, INC. LIQUID AMYLASE (CNPG3) REAGENT SET 08/01/1994
K953211 RANDOX LABORATORIES, LTD. AMYLASE (ETHYLIDENE PNGPG7) KIT 06/21/1996
K873250 ROCHE DIAGNOSTIC SYSTEMS, INC. ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL 10/20/1987
K863719 TECHNICON INSTRUMENTS CORP. AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 11/13/1986
K864356 TRACE SCIENTIFIC LTD. AMYLASE REAGENT 01/21/1987
K790474 WORTHINGTON DIAGNOSTIC SYSTEMS SZAMYL 6.5 05/01/1979


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