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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K071587
Device Name ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
Applicant
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Suite 200
Waltham,  MA  02453
Applicant Contact JAMES DELANEY
Correspondent
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Suite 200
Waltham,  MA  02453
Correspondent Contact JAMES DELANEY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/11/2007
Decision Date 07/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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