510(k) Report

Devices descending from K062923

1 later device reach Microscan Microstrep Plus Panel Tetracycline (0.006 to 16 MCG/ML) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202423MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)Beckman Coulter, Inc.20210—