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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Elution
510(k) Number K992993
Device Name ETEST FOR QUINUPRISTIN/DALFOPRISTIN
Applicant
Ab Biodisk
Dalvagen 10
Solna,  SE 16956
Applicant Contact ANNE BOLMSTROM
Correspondent
Ab Biodisk
Dalvagen 10
Solna,  SE 16956
Correspondent Contact ANNE BOLMSTROM
Regulation Number866.1620
Classification Product Code
LTX  
Date Received09/07/1999
Decision Date 11/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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