510(k) Report

Devices descending from P910065

2 later devices reach Aia-Pack Psa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124056Frend Psa Plus (Reagent Cartridge)Nanoentek, Inc.20131—
+2K162378FREND PSA PLUS (reagent cartridge)Nanoentek USA, Inc.20170—