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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, urea (breath or blood)
510(k) Number K092817
Device Name POC-AS10 AUTO SAMPLER
Applicant
OTSUKA PHARMACEUTICAL CO., LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
OTSUKA PHARMACEUTICAL CO., LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number866.3110
Classification Product Code
MSQ  
Subsequent Product Code
JJQ  
Date Received09/14/2009
Decision Date 03/09/2010
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
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