510(k) Report

Devices descending from K952319

2 later devices reach Contrast & Rapid HCG Urine/Serum TST through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964155Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum TestGenzyme Diagnostics19960—
+1K964156Contrast Strip HCGGenzyme Diagnostics19960—