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- K844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODYCleared 510(K)
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- K820005TOTAL HEMOLYTIC COMPLEMENT TEST KITCleared 510(K)
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- 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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MATRITECH NMP22(TM) TEST KIT
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- ALERE SCARBOROUGH, INC
- Trade Name
- MATRITECH NMP22(TM) TEST KIT
- Generic Name
- System, test, tumor marker, for detection of bladder cancer
- Decision Date
- 7/2/1996
- Days to Decision
- 603 days
- Decision Code
- APPR
- FDA Decision
- Approval