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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 K002139
Device Name ETEST LINEZOLID
Applicant
Ab Biodisk
Dalvagen 10
Solna,  SE 16956
Applicant Contact ANNE BOLMSTORM
Correspondent
Ab Biodisk
Dalvagen 10
Solna,  SE 16956
Correspondent Contact ANNE BOLMSTORM
Regulation Number866.1620
Classification Product Code
LTX  
Date Received07/17/2000
Decision Date 11/08/2000
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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