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510(k) K883185

Device
SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
Applicant
NORFOLK SCIENTIFIC, INC.
510(k) number
K883185
Product code
GHY  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-18
Date received
1988-07-28
Regulation
864.6400
Classification name
Hematocrit, Tube, Rack, Sealer, Holder
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS KELLEY
Address
85 Morse St. Norwood MA US 02062 02062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881186MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PLHelps Products, Inc.1988-05-13

Legacy Summary#

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FDA Review#

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