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510(k) K914847

CD8 MONOCLONAL ANTIBODIES by Gen Trak, Inc. — Product Code LIZ

K914847 is an FDA 510(k) premarket notification submitted by Gen Trak, Inc. for the device "CD8 MONOCLONAL ANTIBODIES". The FDA issued a decision of Substantially Equivalent on June 19, 1992. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Gen Trak, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1992
Date Received
October 28, 1991
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 Gen Trak, Inc.

  • K922085 — MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM (July 28, 1992)
  • K922084 — MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM (July 28, 1992)
  • K914848 — CD4 MONOCLONAL ANTIBODIES (June 19, 1992)
  • K914846 — CD2 MONOCLONAL ANTIBODIES (June 19, 1992)

Other clearances for product code LIZ

  • K860830 — TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD (September 8, 1986)
  • K843062 — TBM-REAGENT FOR T,B CELL & MONOCYTES (April 3, 1985)
  • 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