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

FDA product code LTJ · 34 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.6010
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1997-03-19 – 2026-01-05

LTJ 2026-01-05

Atellica IM Total PSA II (tPSAII)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K251630

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LTJ 2017-05-17

FREND PSA PLUS (reagent cartridge)

Applicant Nanoentek USA, Inc.

K number K162378

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LTJ 2013-05-29

FREND PSA PLUS (REAGENT CARTRIDGE)

Applicant Nanoentek, Inc.

K number K124056

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LTJ 2003-05-15

TPSA FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K031343

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LTJ 2002-12-17

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

Applicant Bayer Corp.

K number K022288

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LTJ 2002-12-17

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant Bayer Diagnostics Corp.

K number K022177

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LTJ 2001-04-24

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

Applicant bioMerieux, Inc.

K number K010550

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LTJ 2001-02-28

DIMENSION PSA FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K003963

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LTJ 2000-10-26

ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY

Applicant Bayer Corp.

K number K002376

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LTJ 2000-10-25

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

Applicant Qualigen, Inc.

K number K003094

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LTJ 2000-08-30

COMPLEXED PSA MICROTITER ELISA

Applicant Oncogene Science, Inc.

K number K002313

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LTJ 2000-08-30

TOTAL PSA MICROTITER ELISA

Applicant Oncogene Science, Inc.

K number K002121

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LTJ 2000-06-28

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

Applicant Qualisys Diagnostics, Inc.

K number K994419

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LTJ 2000-04-13

BAYER PSA ASSAY

Applicant Bayer Corp.

K number K994221

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LTJ 2000-03-09

MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K000566

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LTJ 1999-07-08

QUALISYS PSA IMMUNOASSAY

Applicant Qualisys Diagnostics, Inc.

K number K990234

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LTJ 1999-03-12

VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

Applicant Ortho-Clinical Diagnostics, Inc.

K number K984289

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LTJ 1998-10-27

ELECSYS PSA, MODEL 2010

Applicant Boehringer Mannheim Corp.

K number K982949

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LTJ 1998-10-27

ELECSYS PSA, MODEL # ELECSYS 1010

Applicant Boehringer Mannheim Corp.

K number K982948

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LTJ 1998-10-13

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

Applicant Biocircuits Corp.

K number K981634

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LTJ 1998-08-12

ACS:CENTAUR PSA2 IMMUNOASSAY

Applicant Chiron Diagnostics Corp.

K number K981839

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LTJ 1998-08-03

ACTIVE PSA IRMA (DSL-9700)

Applicant Diagnostic Systems Laboratories, Inc.

K number K973244

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LTJ 1998-08-03

ACTIVE PSA ELISA (DSL-10-9700)

Applicant Diagnostic Systems Laboratories, Inc.

K number K973243

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LTJ 1998-04-23

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K980376

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LTJ 1998-04-21

IMMULITE 2000 3RD GENERATION PSA

Applicant Diagnostic Products Corp.

K number K974842

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LTJ 1998-04-03

ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

Applicant Nichols Institute Diagnostics

K number K980716

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LTJ 1998-02-20

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

Applicant Beckman Instruments, Inc.

K number K974816

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LTJ 1998-01-06

ELECSYS PSA (ON ELECSYS 1010)

Applicant Boehringer Mannheim Corp.

K number K974189

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LTJ 1997-10-31

IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)

Applicant Diagnostic Products Corp.

K number K972021

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LTJ 1997-09-18

PROSTATE SPECIFIC ANTIGEN METHOD

Applicant Dade Chemistry Systems, Inc.

K number K973101

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LTJ 1997-08-22

IMMULITE 2000 PSA

Applicant Diagnostic Products Corp.

K number K972095

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LTJ 1997-07-25

ELECSYS PSA ASSAY

Applicant Boehringer Mannheim Corp.

K number K964351

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LTJ 1997-06-24

OPUS PSA TEST SYSTEM

Applicant Behring Diagnostics, Inc.

K number K964595

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LTJ 1997-03-19

ENZYMUN-TEST PSA

Applicant Boehringer Mannheim Corp.

K number K965085

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