510(k) Report

Devices descending from K991316

2 later devices reach Touch Tear Ige Microassay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083184Tearlab Osmolarity SystemOcusense, Inc.20091—
+2K132066Inflamma DryRapid Pathogen Screening, Inc.201303