510(k) Report

Devices descending from K041946

1 later device reach Acon Spectrum Urine/Serum Pregnancy Test Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071030Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGCApplied Dna Technologies, Inc.20070—