COULTER GEN-S SYSTEM— 510(k) K962988

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K962988 for COULTER GEN-S SYSTEM, Substantially Equivalent on 1996-10-30. Applicant: Coulter Corp.. Device class: 2.

Clearance details

Applicant: Coulter Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1996-08-01
Decision date: 1996-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKL

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 Coulter Corp.

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