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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Leukocyte Peroxidase
510(k) Number K931241
Device Name FAST'N'FLAMMATORY KIT
Applicant
Techlab, Inc.
Vpi Research Park
1861 Pratt Dr.
Blacksburg,  VA  24060
Applicant Contact TRACY WILKINS
Correspondent
Techlab, Inc.
Vpi Research Park
1861 Pratt Dr.
Blacksburg,  VA  24060
Correspondent Contact TRACY WILKINS
Regulation Number864.7675
Classification Product Code
GIA  
Date Received03/11/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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