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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K861016
Device Name GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
Applicant
Gamma Biologicals, Inc.
3700 Mangum Rd., #451-M
Houston,  TX  77092
Applicant Contact JOHN CASE
Correspondent
Gamma Biologicals, Inc.
3700 Mangum Rd., #451-M
Houston,  TX  77092
Correspondent Contact JOHN CASE
Regulation Number866.5640
Classification Product Code
KTN  
Date Received03/18/1986
Decision Date 04/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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