Anesthesiology
Review Panel
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- 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
- LIZAssay, T Lymphocyte Surface Marker2Product Code
- K914847CD8 MONOCLONAL ANTIBODIES2Cleared 510(K)
- K860830TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD2Cleared 510(K)
- K843062TBM-REAGENT FOR T,B CELL & MONOCYTES2Cleared 510(K)
- K842218ANTI-LEU-4 FITC LYSIN C BUFFER2Cleared 510(K)
- K833929WHITE BLOOD CELLS HUMAN TAND B2Cleared 510(K)
- K831053QUANTIGEN T & B CELL ASSAY2Cleared 510(K)
- K820643ORTHO SPECTRUM III & ORTHO-MUNE OK2Cleared 510(K)
- LJDAssay, B Lymphocyte Marker2Product Code
- NIDAssay, Proliferation, In Vitro, T Lymphocyte2Product Code
- PDXFlow Cytometry Calibrator2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
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ORTHO SPECTRUM III & ORTHO-MUNE OK
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K820643
- 510(k) Type
- Traditional
- Applicant
- ORTHO DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/14/1982
- Days to Decision
- 128 days