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Panels › Immunology › Product code LTJ · Class 2

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Regulation 866.6010

1510(k)s in 12 months (34 all time)
1recalls in 12 months (12 all time)
2recalls that name a 510(k)
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Top companies in LTJ

Company510(k)sRecalls
Boehringer Mannheim Corp.50
Bayer Corp.40
Dade Behring, Inc.21
Diagnostic Products Corp.30
Qualigen, Inc.12
BioCheck Inc02
Diagnostic Systems Laboratories, Inc.20
Nanoentek USA, Inc.20
Oncogene Science, Inc.20
Ortho-Clinical Diagnostics, Inc.20
Decided510(k)Device and applicantCode
Jan 5, 2026K251630Atellica IM Total PSA II (tPSAII)
Siemens Healthcare Diagnostics, Inc.
LTJ
May 17, 2017K162378FREND PSA PLUS (reagent cartridge)
Nanoentek USA, Inc.
LTJ
May 29, 2013K124056FREND PSA PLUS (REAGENT CARTRIDGE)
Nanoentek, Inc.
LTJ
May 15, 2003K031343TPSA FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
LTJ
Dec 17, 2002K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Bayer Corp.
LTJ
Dec 17, 2002K022177PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Bayer Diagnostics Corp.
LTJ
Apr 24, 2001K010550VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
bioMerieux, Inc.
LTJ
Feb 28, 2001K003963DIMENSION PSA FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
LTJ
Oct 26, 2000K002376ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
Bayer Corp.
LTJ
Oct 25, 2000K003094FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
Qualigen, Inc.
LTJ
Aug 30, 2000K002313COMPLEXED PSA MICROTITER ELISA
Oncogene Science, Inc.
LTJ
Aug 30, 2000K002121TOTAL PSA MICROTITER ELISA
Oncogene Science, Inc.
LTJ
Jun 28, 2000K994419FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
Qualisys Diagnostics, Inc.
LTJ
Apr 13, 2000K994221BAYER PSA ASSAY
Bayer Corp.
LTJ
Mar 9, 2000K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
Ortho-Clinical Diagnostics, Inc.
LTJ
Jul 8, 1999K990234QUALISYS PSA IMMUNOASSAY
Qualisys Diagnostics, Inc.
LTJ
Mar 12, 1999K984289VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
Ortho-Clinical Diagnostics, Inc.
LTJ
Oct 27, 1998K982949ELECSYS PSA, MODEL 2010
Boehringer Mannheim Corp.
LTJ
Oct 27, 1998K982948ELECSYS PSA, MODEL # ELECSYS 1010
Boehringer Mannheim Corp.
LTJ
Oct 13, 1998K981634BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
Biocircuits Corp.
LTJ
Aug 12, 1998K981839ACS:CENTAUR PSA2 IMMUNOASSAY
Chiron Diagnostics Corp.
LTJ
Aug 3, 1998K973244ACTIVE PSA IRMA (DSL-9700)
Diagnostic Systems Laboratories, Inc.
LTJ
Aug 3, 1998K973243ACTIVE PSA ELISA (DSL-10-9700)
Diagnostic Systems Laboratories, Inc.
LTJ
Apr 23, 1998K980376THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Bayer Corp.
LTJ
Apr 21, 1998K974842IMMULITE 2000 3RD GENERATION PSA
Diagnostic Products Corp.
LTJ
Apr 3, 1998K980716ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
Nichols Institute Diagnostics
LTJ
Feb 20, 1998K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
Beckman Instruments, Inc.
LTJ
Jan 6, 1998K974189ELECSYS PSA (ON ELECSYS 1010)
Boehringer Mannheim Corp.
LTJ
Oct 31, 1997K972021IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
Diagnostic Products Corp.
LTJ
Sep 18, 1997K973101PROSTATE SPECIFIC ANTIGEN METHOD
Dade Chemistry Systems, Inc.
LTJ
Aug 22, 1997K972095IMMULITE 2000 PSA
Diagnostic Products Corp.
LTJ
Jul 25, 1997K964351ELECSYS PSA ASSAY
Boehringer Mannheim Corp.
LTJ
Jun 24, 1997K964595OPUS PSA TEST SYSTEM
Behring Diagnostics, Inc.
LTJ
Mar 19, 1997K965085ENZYMUN-TEST PSA
Boehringer Mannheim Corp.
LTJ

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