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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 K953223
Device Name PIPERACILIN TAZOBACTAM 4 UG
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 Received04/14/1995
Decision Date 08/15/1995
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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