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Astoria-Pacific, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K121101SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITJune 20, 2013
K102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITJuly 15, 2011
K101392NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DFebruary 4, 2011
K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDDecember 14, 2009
K080294ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KITNovember 4, 2008
K010844ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13KSeptember 21, 2001
K990957ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13KMay 11, 1999
K970093TYROSINE 50-HOUR REAGENT KITMarch 19, 1998
K970277URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)December 11, 1997