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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 K961519
Device Name ETEST SUBMISSION FOR AZITHROMYCIN
Applicant
Ab Biodisk
Davagen 10
S-171 36
Solna,  SE
Applicant Contact ANN BOLMSTROM
Correspondent
Ab Biodisk
Davagen 10
S-171 36
Solna,  SE
Correspondent Contact ANN BOLMSTROM
Regulation Number866.1640
Classification Product Code
JWY  
Date Received04/22/1996
Decision Date 07/05/1996
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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