TBM-REAGENT FOR T,B CELL & MONOCYTES— 510(k) K843062

Name: FDA 510(k) clearance K843062
Creator: U.S. Food and Drug Administration
Published: 1985-04-03

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K843062 for TBM-REAGENT FOR T,B CELL & MONOCYTES, Substantially Equivalent on 1985-04-03. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LIZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1984-08-03
Decision date: 1985-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIZ

view all

K914847 — CD8 MONOCLONAL ANTIBODIES1992-06-19
K860830 — TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD1986-09-08
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 Bd Becton Dickinson Vacutainer Systems Preanalytic

view all

K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
K001364 — BD DIRECTIGEN FLU A+B2000-06-28

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