DIGICELL 500— 510(k) K873252

Name: FDA 510(k) clearance K873252
Creator: U.S. Food and Drug Administration
Published: 1987-11-06

Substantially Equivalent

Contraves Medical Instruments, Inc.

FDA 510(k) clearance K873252 for DIGICELL 500, Substantially Equivalent on 1987-11-06. Applicant: Contraves Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Contraves Medical Instruments, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1987-08-17
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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 Contraves Medical Instruments, Inc.

view all

K875346 — AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)1988-04-07
K873271 — DIGICELL 300 SYSTEM1987-11-06

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