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CKB — Acid Phosphatase, Naphthyl Phosphate Class II

FDA Device Classification

Classification Details

Product Code
CKB
Device Class
Class II
Regulation Number
862.1020
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K053612beckman coulterDRI-STAT ACID PHOSPHATASE REAGENTApril 26, 2006
K023840bayer diagnosticsACID PHOSPHATASE ASSAY FOR THE ADVIA 1650January 7, 2003
K991010abbott diagnostics mfgACPMay 19, 1999
K981743olympus americaOLYMPUS AU400 CLINICAL CHEMISTRY ANALYZERJune 9, 1998
K974695roche diagnostic systemsCOBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WMay 21, 1998
K963640olympus americaOLYMPUS ACID PHOSPHATASE REAGENTFebruary 18, 1997
K943366instrumentation laboratoryIL TEST ACID PHOSPHATASEJanuary 29, 1996
K902543crestat diagnosticsACID PHOSPHOTASE REAGENT TEST AND KITSeptember 7, 1990
K902495tech intlACID PHOSPHATASE REAGENT SETJuly 16, 1990
K892393medical analysis systemsACID PHOSPHATASE REAGENTJuly 20, 1989
K884747technicon instrumentsTECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)January 30, 1989
K881204sclavoACP KINETIC TEST (ACID PHOSPHATASE TEST)April 28, 1988
K880798trace americaACID PHOSPHATASE REAGENTApril 18, 1988
K875209diagnostic chemicals, ltd. (usa)ACID PHOSPHATASE (KINETIC) CAT. # 320-06February 1, 1988
K863851sigma diagnosticsACID PHOSPHATASE (ACP) REAGENTOctober 16, 1986
K861675data medical associatesACID PHOSPHATASE PROCEDUREMay 29, 1986
K854223marvic interpharmaVES-TEC/VES-MATICApril 4, 1986
K853949cooper biomedicalDEMAND ACID PHOSPHATASE REAGENTOctober 16, 1985
K850902data medical associatesDATA ZYME ACID PHOSPHATASE PROCEDUREMarch 20, 1985
K840661american dadePARAMAX ACID PHOSPHATASE REAGENTApril 4, 1984