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510(k) K931241

Device
FAST'N'FLAMMATORY KIT
Applicant
TECHLAB, INC.
510(k) number
K931241
Product code
GIA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-03
Date received
1993-03-11
Regulation
864.7675
Classification name
Test, Leukocyte Peroxidase
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TRACY WILKINS
Address
Vpi Research Park 1861 Pratt Dr. Blacksburg VA US 24060 24060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GIA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844402SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDURSigma Chemical Co.1985-01-04
K811011HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTESigma Chemical Co.1981-05-15

Legacy Summary#

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FDA Review#

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