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510(k) K770980

Device
EMATOLOGY DILUENT RESERVOIR CLOSURE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K770980
Product code
GHO  
Decision
Substantially Equivalent (SESE)
Decision date
1977-07-11
Date received
1977-05-31
Regulation
864.6160
Classification name
Hemocytometer
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871671URINOSCOPY FUNNELPortable Medical Laboratories, Inc.1987-05-20

Legacy Summary#

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FDA Review#

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