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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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