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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antistreptolysin - titer/streptolysin o reagent
510(k) Number K901371
Device Name ASO-CUBE(TM)
Original Applicant
DIFCO LABORATORIES, INC.
p.o. box 331058
detroit,  MI  48232 -7058
Original Contact walter s fisher
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received03/23/1990
Decision Date 05/15/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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