ClearanceBrief
Panels › Clinical Chemistry › Product code CIN · Class 2

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Regulation 862.1050

0510(k)s in 12 months (26 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in CIN

Company510(k)sRecalls
Beckman Coulter23
Helena Laboratories50
Hybritech, Inc.30
Immunodiagnostics Systems Ltd03
Metra Biosystems, Inc.20
Sigma Chemical Co.20
Beckman Instruments, Inc.10
Behring Diagnostics, Inc.10
Bioware Products10
California Immuno Diagnostic, Inc.10
Decided510(k)Device and applicantCode
Apr 15, 2024K232904Access Ostase
Beckman Coulter
CIN
Sep 30, 2020K200475IDS-iSYS Ostase BAP
Immunodiagnostic Systems , Ltd., GB
CIN
May 4, 2005K043125ORION DIAGNOSTICA UNIQ PINP RIA
Orion Diagnostica, OY, FI
CIN
May 6, 2002K020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
Helena Laboratories
CIN
Jun 13, 2001K011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
Sebia
CIN
Mar 28, 2000K994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
Beckman Coulter, Inc.
CIN
May 27, 1998K981373ALKPHASE-B ASSAY KIT
Metra Biosystems, Inc.
CIN
Sep 11, 1997K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
Hybritech, Inc.
CIN
Jan 24, 1997K964764OPUS BONE ALP
Behring Diagnostics, Inc.
CIN
Aug 19, 1996K961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
Hybritech, Inc.
CIN
Aug 24, 1995K952768ALKPHASE-B ASSAY KIT
Metra Biosystems, Inc.
CIN
Apr 26, 1994K934013RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
Isolab, Inc.
CIN
Jan 11, 1994K930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
Hybritech, Inc.
CIN
Sep 23, 1992K921578TITAN GEL ALKALINE PHOSPHATASE (HR)
Helena Laboratories
CIN
Jul 30, 1991K912603REP ALP-15, 8, & 4 KITS
Helena Laboratories
CIN
Mar 8, 1989K890269ALKALINE PHOSPHATASE ISOENZYME REAGENTS
Beckman Instruments, Inc.
CIN
Feb 23, 1989K885341TITAN GEL ALKALINE PHOSPHATASE (HR)
Helena Laboratories
CIN
Feb 17, 1989K885024ALKALINE PHOSPHATASE ISOENZYME SYSTEM
Ciba Corning Diagnostics Corp.
CIN
Jun 1, 1987K870890ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
Helena Laboratories
CIN
Feb 25, 1983K830118ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
Corning Medical & Scientific
CIN
Dec 28, 1982K823445ALKPHOR SYSTEM
California Immuno Diagnostic, Inc.
CIN
Feb 2, 1981K810144ALK-PHOS BIOPAK GEL
Bioware Products
CIN
Jan 29, 1980K792548ALKALINE PHOSPHATASE MARKER
Electrophoresis Corp. of America
CIN
Sep 15, 1977K771620ALKALINE PHOSPHATASE ISOENZY. SUB. SET
Pfizer, Inc.
CIN
Aug 3, 1977K771225AP ISOTROL, #A 0140
Sigma Chemical Co.
CIN
Nov 2, 1976K760862PROCEDURE NO. 710-EP FOR ALK.PHOS.
Sigma Chemical Co.
CIN

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