Home / Device Classification / CIN

CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
CIN
Device Class
Class II
Regulation Number
862.1050
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232904beckman coulterAccess OstaseApril 15, 2024
K200475immunodiagnostic systemsIDS-iSYS Ostase BAPSeptember 30, 2020
K043125orion diagnosticaORION DIAGNOSTICA UNIQ PINP RIAMay 4, 2005
K020625helena laboratoriesSPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346May 6, 2002
K011113sebiaHYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAJune 13, 2001
K994278beckman coulterACCESS OSTASE IMMUNOENZYMETRIC ASSAYMarch 28, 2000
K981373metra biosystemsALKPHASE-B ASSAY KITMay 27, 1998
K972666hybritechTANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYSeptember 11, 1997
K964764behring diagnosticsOPUS BONE ALPJanuary 24, 1997
K961573hybritechTANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYAugust 19, 1996
K952768metra biosystemsALKPHASE-B ASSAY KITAugust 24, 1995
K934013isolabRESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KITApril 26, 1994
K930810hybritechTANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYJanuary 11, 1994
K921578helena laboratoriesTITAN GEL ALKALINE PHOSPHATASE (HR)September 23, 1992
K912603helena laboratoriesREP ALP-15, 8, & 4 KITSJuly 30, 1991
K890269beckman instrumentsALKALINE PHOSPHATASE ISOENZYME REAGENTSMarch 8, 1989
K885341helena laboratoriesTITAN GEL ALKALINE PHOSPHATASE (HR)February 23, 1989
K885024ciba corning diagnosticsALKALINE PHOSPHATASE ISOENZYME SYSTEMFebruary 17, 1989
K870890helena laboratoriesALKALINE PHOSPHATASE INDOLYL BLUE REAGENTJune 1, 1987
K830118corning medical and scientificALKALINE PHOSPHATES ISOENZYME SUBSTRATEFebruary 25, 1983