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JFH — Acid Phosphatase (Prostatic), Tartrate Inhibited Class II

FDA Device Classification

Classification Details

Product Code
JFH
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
K000257diagnostic productsIMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6February 23, 2000
K981573united biotechUBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVESeptember 15, 1998
K964756wano-techPROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KITApril 23, 1997
K931701diagnostic productsIMMULITE PAPJanuary 27, 1994
K925377abbott laboratoriesIMX PAPJanuary 13, 1993
K921745hybritechHYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOJuly 30, 1992
K902937diagnostic productsMILENIA PAP IRMA CATALOG #: MKPA1, XSeptember 21, 1990
K901933diagnostic productsCOAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2June 28, 1990
K895723diagnostic productsIRMA-COUNT(TM) PAP, (RKPA1, RKPA2)October 31, 1989
K893508baxter healthcarePROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTIAugust 4, 1989
K884748technicon instrumentsTECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)January 30, 1989
K873903abbott laboratoriesABBOTT PAP-EIADecember 1, 1987
K864945hybritechTANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYJanuary 5, 1987
K863832pointe scientific, incNAPHTHYL PHOSPHATE, ACID PHOSPHATASEDecember 16, 1986
K852845diagnostic productsPROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAYSeptember 4, 1985
K851950hybritechTANDEM E PAPJune 25, 1985
K844679diagnostic systems laboratoriesDSL PAP RIA -DSL#3100April 29, 1985
K844968cetusEPICHROME PAPFebruary 7, 1985
K843230ventrex laboratoriesVENTREZYME PAP KIT IMMUNOASSAY PROSTATICSeptember 4, 1984
K831670ortho diagnostic systemsORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNOAugust 24, 1983