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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K090940
Device Name SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
Applicant
Astoria-Pacific, Inc.
15130 SE 82nd Dr.
Clackamas,  OR  97015
Applicant Contact CHARLES A PETERSON
Correspondent
Astoria-Pacific, Inc.
15130 SE 82nd Dr.
Clackamas,  OR  97015
Correspondent Contact CHARLES A PETERSON
Regulation Number862.1660
Classification Product Code
JJT  
Date Received04/03/2009
Decision Date 12/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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