510(k) Report

Devices descending from K220016

3 later devices reach Viramed Borrela All-In-One ViraChip Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.20250—
+1K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.20250—
+1K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.20240—