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- MiscellaneousMiscellaneous
- OYMProstrate Cancer Genes Nucleic Acid Amplification Test System3Product Code
- KTJSystem, Test, Alpha-Fetoprotein, Ria3Product Code
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects3Product Code
- LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum3Product Code
- MANAssay, Interleukin3Product Code
- MJBAntigen, Cancer 5493Product Code
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer3Product Code
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions3Product Code
- P080008VIDAS FREE PSA RT ASSAYAPWDPMA Approval
- P060005IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYSAPPRPMA Approval
- P980007AXSYM FREE PSAAPPRPMA Approval
- P020027DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSAPPRPMA Approval
- P970038TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAYAPPRPMA Approval
- P950021ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYAPPRPMA Approval
- MYZKit, Test (Donors), For Bloodborne Pathogen2Product Code
- MZATest, Equipment, Automated Bloodborne PathogenNProduct Code
- MZETest, Donor, Cmv2Product Code
- MZFTest, Hiv Detection3Product Code
- MZLKit, Test, Quality Control For EndotoxinNProduct Code
- NAFAntigen(Complexed),Prostate Specific,(Cpsa)3Product Code
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer3Product Code
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer3Product Code
- OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaFProduct Code
- OCBRt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection3Product Code
- OTRResearch Use Only/Immunology DevicesNProduct Code
- OWDSomatic Gene Mutation Detection System3Product Code
- OYAP2psa3Product Code
- OYYLeukemia Translocation Panel Multiplex TestNProduct Code
- PILTest For Periprosthetic Joint InfectionNProduct Code
- QLCInterleukin 6NProduct Code
- QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer3Product Code
- QSEAlzheimer’S Disease Pathology Assessment Test2Product Code
- QWQAssays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors3Product Code
- SADJapanese Encephalitis Virus Immunological/Serology TestNProduct Code
- SETImmunoassay Blood Test For Amyloid Pathology Assessment2Product Code
- SFCNeurologic Disease Risk Assessment Molecular Test2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
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IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
- Trade Name
- IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
- Generic Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision Date
- 5/11/2007
- Days to Decision
- 451 days
- Decision Code
- APPR
- FDA Decision
- Approval