510(k) Report

Devices descending from K010844

3 later devices reach Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090123Neonatal Biotinidase Kit, Model 3018Perkinelmer, Inc.20101—
+1K080294Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitAstoria-Pacific, Inc.20080—
+2K131284GSP Neonatal Biotinidase KitWallac OY20130—