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
- 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
- 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
QUANTIGEN T & B CELL ASSAY
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K831053
- 510(k) Type
- Traditional
- Applicant
- BIO-RAD
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/8/1983
- Days to Decision
- 129 days