510(k) Report

Devices descending from K132834

3 later devices reach Fastep S10 HCG Serum/Urine Combo Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.20222—
+2K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.20260—
+2K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.20240—