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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
510(k) Number K102643
Device Name SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
Applicant
Astoria-Pacific, Inc.
15130 SE 82nd Dr.
Clackamas,  OR  97015
Applicant Contact JASON C REYNOLDS
Correspondent
Astoria-Pacific, Inc.
15130 SE 82nd Dr.
Clackamas,  OR  97015
Correspondent Contact JASON C REYNOLDS
Regulation Number862.1315
Classification Product Code
KQP  
Subsequent Product Code
JJQ  
Date Received09/14/2010
Decision Date 07/15/2011
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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