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LTJ — Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Class II

FDA Device Classification

Classification Details

Product Code
LTJ
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251630siemens healthcare diagnosticsAtellica IM Total PSA II (tPSAII)January 5, 2026
K162378nanoentek usaFREND PSA PLUS (reagent cartridge)May 17, 2017
K124056nanoentekFREND PSA PLUS (REAGENT CARTRIDGE)May 29, 2013
K031343dade behringTPSA FLEX REAGENT CARTRIDGEMay 15, 2003
K022177bayer diagnosticsPROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMDecember 17, 2002
K022288bayerCOMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED December 17, 2002
K010550biomerieuxVIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428April 24, 2001
K003963dade behringDIMENSION PSA FLEX REAGENT CARTRIDGEFebruary 28, 2001
K002376bayerADVIA: CENTAUR AND ACS: 180 CPSA ASSAYOctober 26, 2000
K003094qualigenFASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZEROctober 25, 2000
K002121oncogene scienceTOTAL PSA MICROTITER ELISAAugust 30, 2000
K002313oncogene scienceCOMPLEXED PSA MICROTITER ELISAAugust 30, 2000
K994419qualisys diagnosticsFASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEMJune 28, 2000
K994221bayerBAYER PSA ASSAYApril 13, 2000
K000566ortho-clinical diagnosticsMODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIMarch 9, 2000
K990234qualisys diagnosticsQUALISYS PSA IMMUNOASSAYJuly 8, 1999
K984289ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCMarch 12, 1999
K982948boehringer mannheimELECSYS PSA, MODEL # ELECSYS 1010October 27, 1998
K982949boehringer mannheimELECSYS PSA, MODEL 2010October 27, 1998
K981634biocircuitsBIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOSOctober 13, 1998