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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Yeast
510(k) Number K832406
Device Name QUANTUM II YEAST IDENT. SYSTEM
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Regulation Number866.2660
Classification Product Code
JXC  
Date Received07/21/1983
Decision Date 09/26/1983
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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