Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- DHXSystem, Test, Carcinoembryonic Antigen2Product Code
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer2Product Code
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers2Product Code
- K251630Atellica IM Total PSA II (tPSAII)2Cleared 510(K)
- K162378FREND PSA PLUS (reagent cartridge)2Cleared 510(K)
- K124056FREND PSA PLUS (REAGENT CARTRIDGE)2Cleared 510(K)
- K031343TPSA FLEX REAGENT CARTRIDGE2Cleared 510(K)
- K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM2Cleared 510(K)
- K022177PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM2Cleared 510(K)
- P000021DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGEAPPRPMA Approval
- K010550VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 4282Cleared 510(K)
- K003963DIMENSION PSA FLEX REAGENT CARTRIDGE2Cleared 510(K)
- P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKAPPRPMA Approval
- P000021Dimension Vista TPSA Flex reagent cartridge2PMA Approval
- P000021Dimension Vista TPSA Flex reagent cartridge (K6451)2PMA Approval
- P000021Dimension TPSA Flex reagent cartridge2PMA Approval
- P000021Dimension Vista TPSA Flex reagent cartridge2PMA Approval
- P000027Elecsys free PSA Test System2PMA Approval
- P000021Dimension Vista TPSA Flex reagent cartridge (K6451)2PMA Approval
- P000027Elecsys free PSA2PMA Approval
- P000021Dimension TPSA Flex Reagent Cartridge2PMA Approval
- P000027Elecsys free PSA2PMA Approval
- P000021Dimension TPSA Flex Reagent Cartridge2PMA Approval
- P000027Elecsys free PSA2PMA Approval
- P000021Dimension Vista TPSA Flex reagent cartridge (K6451)2PMA Approval
- P000021Dimension Vista TPSA Flex reagent cartridge2PMA Approval
- P000027Elecsys Free PSA Immunoassay2PMA Approval
- P000021Dimension TPSA Flex reagent cartridge (RF451)2PMA Approval
- P000027Elecsys free PSA Immunoassay2PMA Approval
- P000021Dimension TPSA Flex reagent cartridge (RF451)2PMA Approval
- P000021Dimension TPSA Flex reagent cartridge2PMA Approval
- P000027Elecsys free PSA, free PSA Calset, free PSA CalCheck2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451)2PMA Approval
- P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK2PMA Approval
- P910065AIA-PACK PA PSA, ST AIA-PACK PA PSA2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE2PMA Approval
- P910065ST AIA-PACK PA2PMA Approval
- P910007ABBOTT AXSYM/TOTAL PSA2PMA Approval
- P910007ABBOTT IMX TOTAL PSA2PMA Approval
- P910007ABBOTT AXSYM TOTAL PSA2PMA Approval
- P930027IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE2PMA Approval
- P910065ST AIA-PACK PA2PMA Approval
- P850048ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS2PMA Approval
- P930027IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA2PMA Approval
- P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK2PMA Approval
- P850048ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM2PMA Approval
- P850048ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER2PMA Approval
- P000021DIMENSION TPSA FLEX REAGENT CARTRIDGE2PMA Approval
- P910065AIA-PACK PA2PMA Approval
- P910007IMX AND AXSYM PSA2PMA Approval
- P000027ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK2PMA Approval
- P950021TOTAL PSA MICROTITER ELISA2PMA Approval
- P950021TOTAL PSA MICROTITER ELISA2PMA Approval
- P990056ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET2PMA Approval
- P950021ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS2PMA Approval
- P000021DIMENSION PSA FLEX REAGENT CARTRIDGE2PMA Approval
- P000021DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE2PMA Approval
- P930027IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 20002PMA Approval
- P950021ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY2PMA Approval
- P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK2PMA Approval
- K002376ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY2Cleared 510(K)
- K003094FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER2Cleared 510(K)
- K002313COMPLEXED PSA MICROTITER ELISA2Cleared 510(K)
- K002121TOTAL PSA MICROTITER ELISA2Cleared 510(K)
- K994419FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM2Cleared 510(K)
- K994221BAYER PSA ASSAY2Cleared 510(K)
- K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS2Cleared 510(K)
- P910065AIA PACK PA2PMA Approval
- P850048ACCESS(R) HYBRITECH PSA ASSAY2PMA Approval
- P910065ST AIA-PACK PA2PMA Approval
- P850048TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY2PMA Approval
- K990234QUALISYS PSA IMMUNOASSAY2Cleared 510(K)
- P950021BAYER IMMUNO 1 SYSTEM2PMA Approval
- P850048TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- K984289VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK2Cleared 510(K)
- P920030CIBA CORNING ACS PSA IMMUNOASSAY2PMA Approval
- P920030CIBA CORNING ACS PSA IMMUNOASSAY2PMA Approval
- K982949ELECSYS PSA, MODEL 20102Cleared 510(K)
- K982948ELECSYS PSA, MODEL # ELECSYS 10102Cleared 510(K)
- K981634BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS2Cleared 510(K)
- K981839ACS:CENTAUR PSA2 IMMUNOASSAY2Cleared 510(K)
- K973243ACTIVE PSA ELISA (DSL-10-9700)2Cleared 510(K)
- K973244ACTIVE PSA IRMA (DSL-9700)2Cleared 510(K)
- P930027IMMULITE PSA CATALOG # LKPS1,5)2PMA Approval
- K980376THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM2Cleared 510(K)
- K974842IMMULITE 2000 3RD GENERATION PSA2Cleared 510(K)
- K980716ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY2Cleared 510(K)
- K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 332292Cleared 510(K)
- K974189ELECSYS PSA (ON ELECSYS 1010)2Cleared 510(K)
- K972021IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)2Cleared 510(K)
- K973101PROSTATE SPECIFIC ANTIGEN METHOD2Cleared 510(K)
- K972095IMMULITE 2000 PSA2Cleared 510(K)
- P910007ABBOTT IMX PSA2PMA Approval
- K964351ELECSYS PSA ASSAY2Cleared 510(K)
- K964595OPUS PSA TEST SYSTEM2Cleared 510(K)
- K965085ENZYMUN-TEST PSA2Cleared 510(K)
- P930027IMMULITE(R) THIRD GENERATION PSA2PMA Approval
- P850048TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY2PMA Approval
- P920030CIBA CORNING ACS PSA IMMUNOASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P910007ABBOTT AXSYM PSA (LIST 7A49)2PMA Approval
- P910007ABBOTT IMX PSA2PMA Approval
- P910007ABBOTT IMX(R) PSA*2PMA Approval
- P850048HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC2PMA Approval
- P850048HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC2PMA Approval
- P850048HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY2PMA Approval
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)2Product Code
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder2Product Code
- MOISystem, Test, Immunological, Antigen, Tumor2Product Code
- MSWSystem, Test, Thyroglobulin2Product Code
- MUTKit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)2Product Code
- NCWSystem, Test, Her-2/Neu, Monitoring2Product Code
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer2Product Code
- NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment2Product Code
- NTYSystem, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer2Product Code
- NVACancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma2Product Code
- OAUDes-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma2Product Code
- OIUTest, Epithelial Ovarian Tumor Associated Antigen (He4)2Product Code
- OVKCytokeratin Fragments 21-1 Eia Kit2Product Code
- ONXOvarian Adnexal Mass Assessment Score Test System2Product Code
- QTEThymidine Kinase Activity2Product Code
- QXSChromogranin A2Product Code
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ENZYMUN-TEST PSA
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K965085
- 510(k) Type
- Traditional
- Applicant
- Boehringer Mannheim Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/19/1997
- Days to Decision
- 90 days
- Submission Type
- Summary