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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Lidocaine
510(k) Number K090282
Device Name QMS LIDOCAINE
Applicant
Thermo Fisher Scientific, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268 -9046
Applicant Contact JACK ROGERS
Correspondent
Thermo Fisher Scientific, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268 -9046
Correspondent Contact JACK ROGERS
Regulation Number862.3555
Classification Product Code
KLR  
Date Received02/05/2009
Decision Date 05/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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