ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)— 510(k) K761289

Name: FDA 510(k) clearance K761289
Creator: U.S. Food and Drug Administration
Published: 1977-03-28

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K761289 for ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800), Substantially Equivalent on 1977-03-28. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1976-12-20
Decision date: 1977-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKL

view all

K152776 — Glocyte Automated Cell Counter System2016-05-27
K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE2010-08-31
K071652 — HEMOCUE WBC SYSTEM2007-10-25
K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM2005-12-07
K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE2005-03-23

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.