510(k) Report

Devices descending from K082688

15 later devices reach Pro HMPV+ Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131813Quidel Molecular RSV + HMPV AssayQuidel Corp.20137—
+1K122189Quidel Molecular RSV + HMPV AssayQuidel Corp.20130—
+1K123838Pro HMPV+ AssayGen-Probe Prodesse, Inc.20131—
+1K112490Quidel Molecular HMPV AssayQuidel Corp.20112—
+1K090073D3 Dfa Metapneumovirus Identification KitDiagnostic Hybrids, Inc.20092—
+2K230349Lyra RSV+hMPV AssayQuidel Corporation20230—
+2K171974Solana RSV+hMPV AssayQuidel Corporation20170—
+2K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc.201642
+2K132200Pro HMPV+ AssayGen-Probe Prodesse, Inc.20130—
+2K093233D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc.20090—
+2K091171D3 Ultra Duet Dfa Respiratory Virus Identification KitDiagnostic Hybrids, Inc.20090—
+3K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+4K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+4K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+5K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—