510(k) Report

Devices descending from K183048

3 later devices reach Quantisal II Oral Fluid Collection Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation20230—
+1K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation20201—
+2K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation20230—