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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzymatic methods, galactose
510(k) Number K121101
Model 81-2000-60K, 81-2000-5K
Device Name SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
Original Applicant
ASTORIA-PACIFIC,INC.
15130 s.e. 82nd dr.
clackamas,  OR  97015
Original Contact charles a peterson
Regulation Number862.1310
Classification Product Code
JIA  
Date Received04/11/2012
Decision Date 06/20/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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