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510(k) K874188

Device
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
Applicant
COULTER ELECTRONICS, INC.
510(k) number
K874188
Product code
GKM  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-19
Date received
1987-10-14
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
RICHARDSON-JONES
Address
745 W. 83rd St. Hialeah FL US 33014 33014

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
K854685DIGITAL-9 KEY LEUCOCYTE COUNTERFuture Impex Corp.1986-04-04
K841026MANUAL BLOOD CELL COUNTING DEVICEInstrumentation Laboratory CO1984-04-04
K771580TEKTALLY IIScientific Products1977-09-02

Legacy Summary#

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FDA Review#

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