CD8 MONOCLONAL ANTIBODIES— 510(k) K914847

Substantially Equivalent

Gen Trak, Inc.

FDA 510(k) clearance K914847 for CD8 MONOCLONAL ANTIBODIES, Substantially Equivalent on 1992-06-19. Applicant: Gen Trak, Inc.. Device class: 2.

Clearance details

Applicant: Gen Trak, Inc.
Product code: Code LIZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1991-10-28
Decision date: 1992-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth Meeting, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIZ

K860830 — TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD1986-09-08
K843062 — TBM-REAGENT FOR T,B CELL & MONOCYTES1985-04-03
K842218 — ANTI-LEU-4 FITC LYSIN C BUFFER1984-12-27
K833929 — WHITE BLOOD CELLS HUMAN TAND B1984-02-03
K831053 — QUANTIGEN T & B CELL ASSAY1983-08-08

More clearances from Gen Trak, Inc.

K922084 — MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM1992-07-28
K922085 — MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM1992-07-28
K914846 — CD2 MONOCLONAL ANTIBODIES1992-06-19
K914848 — CD4 MONOCLONAL ANTIBODIES1992-06-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.