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CKE — Acid Phosphatase, Thymolphthale Inmonophosphate Class II

FDA Device Classification

Classification Details

Product Code
CKE
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
K914167eastman kodakCLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASEMarch 17, 1992
K915705tech intlACID PHOSPHATASE REAGENT SETFebruary 27, 1992
K873726king diagnosticsACID PHOSPHATASE TESTJanuary 27, 1988
K864230e.i. dupont de nemours and coDIMENSION (TM) CLINICAL CHEMISTRY SYSTEMNovember 28, 1986
K860476sterling diagnosticsACID PHOSPHATASE REAGENT SETMarch 5, 1986
K843380diagnostic chemicals, ltd. (usa)ACID PHOSPHATASE ASSAY KITSeptember 20, 1984
K821526anco medical reagents and assocACID PHOSPHATASE REAGENT SETJune 10, 1982
K800693stanbio laboratorySTANBIO PROSTATIC ACID PHOSPHATASE TESTApril 16, 1980
K790524data medical associatesDATA-ZYME ACIA PHOSPHATASE PROCEDUREMay 23, 1979