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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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