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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Quality Control For Blood Banking Reagents
510(k) Number K800658
Device Name RST-SERIES CONTROL
Applicant
GAMMA BIOLOGICALS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GAMMA BIOLOGICALS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.9650
Classification Product Code
KSF  
Date Received03/26/1980
Decision Date 04/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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