RETICCOUNT SOFTWARE— 510(k) K880636

Name: FDA 510(k) clearance K880636
Creator: U.S. Food and Drug Administration
Published: 1988-03-21

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K880636 for RETICCOUNT SOFTWARE, Substantially Equivalent on 1988-03-21. 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: 1988-02-16
Decision date: 1988-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, 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

Recalls naming K880636

K-number listed on FDA's recall record

Z-1390-2016 — BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnosticsClass III·Terminated·Becton, Dickinson and Company, BD Biosciences·20160318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K880636.

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