FDA.reportPublic FDA data

510(k) K854685

Device
DIGITAL-9 KEY LEUCOCYTE COUNTER
Applicant
FUTURE IMPEX CORP.
510(k) number
K854685
Product code
GKM  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-04
Date received
1985-11-20
Regulation
864.6160
Classification name
Hand-tally, Differential
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MORAD DAVOUDZADEH
Address
2076 Deer Park Ave. Deerpark NY US 11729 11729

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874188COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STACoulter Electronics, Inc.1988-01-19
K841026MANUAL BLOOD CELL COUNTING DEVICEInstrumentation Laboratory CO1984-04-04
K771580TEKTALLY IIScientific Products1977-09-02

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases