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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Varicella-Zoster
510(k) Number K842096
Device Name GLB VARICELLA-ZOSTER VIRUS FLUORESCENT
Applicant
Great Lakes Bioscience
P.O. Box 364
St. Joseph,  MI  49085
Applicant Contact WAYNE E GLEIBER
Correspondent
Great Lakes Bioscience
P.O. Box 364
St. Joseph,  MI  49085
Correspondent Contact WAYNE E GLEIBER
Regulation Number866.3900
Classification Product Code
GQX  
Date Received05/25/1984
Decision Date 01/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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