QLIA IMMUNOCHEMISTRY SYSTEM— 510(k) K883349

Name: FDA 510(k) clearance K883349
Creator: U.S. Food and Drug Administration
Published: 1988-09-07

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K883349 for QLIA IMMUNOCHEMISTRY SYSTEM, Substantially Equivalent on 1988-09-07. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JZT
Device class: Class 1
Regulation: 21 CFR 866.4520
Advisory panel: Immunology
Date received: 1988-08-09
Decision date: 1988-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZT

view all

K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER1996-09-05
K882677 — STAT-20 FLUOROMETER1988-07-12
K864699 — FLUORESCENCE CONCENTRATION ANALYZER (FCA)1986-12-22
K863434 — THE FIAX 5000 FLUOROMETER1986-10-29
K862674 — PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM1986-08-15

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.