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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name manual antimicrobial susceptibility test systems
510(k) Number K950328
Device Name AMOXICILLIN/CLAVULANIC ACID 2/1
Applicant
AB BIODISK NORTH AMERICA, INC.
PYRAMIDVAGEN, 7
S-17136 SOLNA, SWEDEN,  SE
Applicant Contact ANNE BOLMSTROM
Correspondent
AB BIODISK NORTH AMERICA, INC.
PYRAMIDVAGEN, 7
S-17136 SOLNA, SWEDEN,  SE
Correspondent Contact ANNE BOLMSTROM
Regulation Number866.1640
Classification Product Code
JWY  
Date Received01/19/1995
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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