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510(k) K841465

Device
GENERAL DIAGNOSTICS PLATELET ANTIBODY
Applicant
GENERAL DIAGNOSTICS
510(k) number
K841465
Product code
LLG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-02
Date received
1984-04-09
Regulation
864.5425
Classification name
Kit, Igg, Platelet Associated
Medical specialty
Hematology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K840257RAPID IMMUNO-ASSAY SYSApplied Polytechnology, Inc.1984-04-19

Legacy Summary#

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FDA Review#

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