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510(k) K843062

TBM-REAGENT FOR T,B CELL & MONOCYTES by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LIZ

K843062 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TBM-REAGENT FOR T,B CELL & MONOCYTES". The FDA issued a decision of Substantially Equivalent on April 3, 1985. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1985
Date Received
August 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, T Lymphocyte Surface Marker
Device Class
Class II
Regulation Number
864.5220
Review Panel
IM
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code LIZ

  • K914847 — CD8 MONOCLONAL ANTIBODIES (June 19, 1992)
  • K860830 — TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD (September 8, 1986)
  • K842218 — ANTI-LEU-4 FITC LYSIN C BUFFER (December 27, 1984)
  • K833929 — WHITE BLOOD CELLS HUMAN TAND B (February 3, 1984)
  • K831053 — QUANTIGEN T & B CELL ASSAY (August 8, 1983)
  • K820643 — ORTHO SPECTRUM III & ORTHO-MUNE OK (July 14, 1982)

FDA data resources