510(k) Report

Devices descending from K061101

7 later devices reach D3 Ultra Dfa Respiratory Virus Screening & ID Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093415D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitDiagnostic Hybrids, Inc.20090—
+1K093233D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc.20090—
+1K092882D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification KitDiagnostic Hybrids, Inc.20090—
+1K091171D3 Ultra Duet Dfa Respiratory Virus Identification KitDiagnostic Hybrids, Inc.20090—
+1K092300Modification to D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc.20090—
+1K081746D3 Duet Dfa Influenza a/Respiratory Virus Screening KitDiagnostic Hybrids, Inc.20080—
+1K081928D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc.20084—