CC-700 Seven Parameter, Automated Hemaa

FDA 510(k) K821238 · Dysmex

Substantially Equivalent

510(k) numberK821238

Submission

Device name
CC-700 Seven Parameter, Automated Hemaa
Applicant
Dysmex
Mchenry, IL, US
Received
April 28, 1982
Decision date
May 28, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKL – Counter, Cell, Automated (Particle Counter)
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5200
Specialty
Hematology

Other 510(k)s with product code GKL

510(k)DeviceApplicantDecision
K152776Glocyte Automated Cell Counter SystemGKL · Traditional Advanced Instruments, Inc.05/27/2016SE
K091539Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional Iris Diagnostics08/31/2010SE
K071652Hemocue WBC SystemGKL · Traditional Hemocue AB10/25/2007SE
K051693Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional Bayer Healthcare, LLC12/07/2005SE
K050235Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional Iris International, Inc.03/23/2005SE
K032677Sysmex POCH-100IGKL · Traditional Sysmex America, Inc.02/11/2004SE
K022331Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special Bayer Diagnostics Corp.09/11/2002SE
K001683Sysmex R-500GKL · Traditional Sysmex Corporation of America08/21/2000SE
K991070Coulter Z2 AnalyzerGKL · Traditional Coulter Corp.05/11/1999SE
K981950Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional Sysmex Corp.11/03/1998SE

Questions and answers

When was CC-700 Seven Parameter, Automated Hemaa cleared by the FDA?

CC-700 Seven Parameter, Automated Hemaa (K821238) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 30 days after the submission was received.

What is the product code of K821238?

The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.