510(k) Report

Devices descending from K993065

4 later devices reach Acon Combo Pregnancy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050955Lifesign Dxpress, Model LSR2000Princeton BioMeditech Corp.20060—
+1K051841WH Accu Test One-Step Urine/Serum Combo Pregnancy TestW.H.P.M., Inc.20050—
+1K041946Acon Spectrum Urine/Serum Pregnancy Test DeviceACON Laboratories, Inc.20041—
+2K071030Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGCApplied Dna Technologies, Inc.20070—