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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K023766
Device Name ACON STREP A TWIST TEST DEVICE
Applicant
ACON LABORATORIES CO.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
ACON LABORATORIES CO.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD TUNG
Regulation Number866.3740
Classification Product Code
GTY  
Date Received11/12/2002
Decision Date 02/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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