510(k) Report

Devices descending from K945951

2 later devices reach Quikpac II, One Step HCG Combo Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984077Instant-View Pregnancy Combo TestAlfa Scientific Designs, Inc.19990—
+1K984080Instant-View Pregnancy Combo Dip-Strip TestAlfa Scientific Designs, Inc.19990—