FDA 510(k) Applications for Medical Device Product Code "CIN"
(Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K994278 BECKMAN COULTER, INC. ACCESS OSTASE IMMUNOENZYMETRIC ASSAY 03/28/2000
K890269 BECKMAN INSTRUMENTS, INC. ALKALINE PHOSPHATASE ISOENZYME REAGENTS 03/08/1989
K964764 BEHRING DIAGNOSTICS, INC. OPUS BONE ALP 01/24/1997
K810144 BIOWARE PRODUCTS ALK-PHOS BIOPAK GEL 02/02/1981
K823445 CALIFORNIA IMMUNO DIAGNOSTIC, INC. ALKPHOR SYSTEM 12/28/1982
K885024 CIBA CORNING DIAGNOSTICS CORP. ALKALINE PHOSPHATASE ISOENZYME SYSTEM 02/17/1989
K830118 CORNING MEDICAL & SCIENTIFIC ALKALINE PHOSPHATES ISOENZYME SUBSTRATE 02/25/1983
K792548 ELECTROPHORESIS CORP. OF AMERICA ALKALINE PHOSPHATASE MARKER 01/29/1980
K870890 HELENA LABORATORIES ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT 06/01/1987
K912603 HELENA LABORATORIES REP ALP-15, 8, & 4 KITS 07/30/1991
K020625 HELENA LABORATORIES SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 05/06/2002
K885341 HELENA LABORATORIES TITAN GEL ALKALINE PHOSPHATASE (HR) 02/23/1989
K921578 HELENA LABORATORIES TITAN GEL ALKALINE PHOSPHATASE (HR) 09/23/1992
K972666 HYBRITECH, INC. TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY 09/11/1997
K930810 HYBRITECH, INC. TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY 01/11/1994
K961573 HYBRITECH, INC. TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY 08/19/1996
K934013 ISOLAB, INC. RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT 04/26/1994
K952768 METRA BIOSYSTEMS, INC. ALKPHASE-B ASSAY KIT 08/24/1995
K981373 METRA BIOSYSTEMS, INC. ALKPHASE-B ASSAY KIT 05/27/1998
K043125 ORION DIAGNOSTICA OY ORION DIAGNOSTICA UNIQ PINP RIA 05/04/2005
K771620 PFIZER, INC. ALKALINE PHOSPHATASE ISOENZY. SUB. SET 09/15/1977
K011113 SEBIA HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) 06/13/2001
K771225 SIGMA CHEMICAL CO. AP ISOTROL, #A 0140 08/03/1977
K760862 SIGMA CHEMICAL CO. PROCEDURE NO. 710-EP FOR ALK.PHOS. 11/02/1976


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