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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 K945433
Device Name ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
Applicant
AB BIODISK
PYRAMIDVAGEN 7
SOLNA,  SE S-171 36
Applicant Contact ANNE BOLMSTROM
Correspondent
AB BIODISK
PYRAMIDVAGEN 7
SOLNA,  SE S-171 36
Correspondent Contact ANNE BOLMSTROM
Regulation Number866.1640
Classification Product Code
JWY  
Date Received10/24/1994
Decision Date 03/17/1995
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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