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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigens, all types, escherichia coli
510(k) Number K061889
Device Name BIOSTAR OIA SHIGATOX
Applicant
INVERNESS MEDICAL-BIOSTAR INC.
331 SOUTH 104TH ST.
LOUISVILLE,  CO  80516
Applicant Contact ROBIN C HART
Correspondent
INVERNESS MEDICAL-BIOSTAR INC.
331 SOUTH 104TH ST.
LOUISVILLE,  CO  80516
Correspondent Contact ROBIN C HART
Regulation Number866.3255
Classification Product Code
GMZ  
Date Received07/03/2006
Decision Date 12/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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