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510(k) K800037

Device
PLATELET RETENTION (ADHESION) COLUMNS
Applicant
HEMOMETRIX
510(k) number
K800037
Product code
JBZ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-05
Date received
1980-01-07
Regulation
864.6650
Classification name
Study, Platelet Adhesive
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JBZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K771523LATELET RETENTION COLUMNBd Becton Dickinson Vacutainer Systems Preanalytic1977-11-22
K771678THROMBO-SCREEN PLATELET ADHESIONBay Area Hema. Onco. Clinic. & Res. L1977-11-22

Legacy Summary#

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FDA Review#

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