510(k) Report

Devices descending from K963641

36 later devices reach Streptococcus Mic Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021184Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinDade Microscan, Inc.20020—
+1K021181Microscan Microstrep Plus Panel New Anticrobial-ClarithromycinDade Microscan, Inc.20020—
+1K021018Microscan Microstrep Plus Panel - ChloramphenicolDade Microscan, Inc.20020—
+1K021078Microscan Microstrep Plus Panel New Antimicrobial-ErythromycinDade Microscan, Inc.20020—
+1K021169Microstrep Plus Panel, AzithromycinDade Microscan, Inc.20021—
+1K021110Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneDade Microscan, Inc.20021—
+1K021111Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeDade Microscan, Inc.20021—
+1K021188Microscan Microstrep Plus Panel New Antimicrobial-CefepimeDade Microscan, Inc.20021—
+1K020938Microscan Microstrep Plus Panel-MeropenemDade Microscan, Inc.20021—
+1K020939Microscan Microstrep Plus Panel-TetracyclineDade Microscan, Inc.20021—
+1K020820Microscan Microstep Plus Panel New Antimicrobial - CefuroximeDade Behring, Inc.20021—
+1K020822Microscan Microstep Plus Panel New Antimicrobial - VancomycinDade Behring, Inc.20021—
+1K020937Microscan Microstrep Plus Panel-Amoxicillin/Clavulanic AcidDade Microscan, Inc.20021—
+1K020627Microscan Microstrep Plus Panel New Antimicrobial-GatifloxacinDade Microscan, Inc.20020—
+1K021037Microstrep Plus Panel with AmpicillinDade Behring, Inc.20020—
+1K020686Microscan Microstrep Plus Panel New Antimicrobial - Trimethoprim/SulfamethoxazoleDade Microscan, Inc.20020—
+1K020691Microscan Microstrep Plus Panel New Antimicrobial - CefaclorDade Microscan, Inc.20021—
+1K020626Microscan Microstrep Plus Panel New Antimicrobial-PenicillinDade Microscan, Inc.200202
+1K020556Microscan Microstrep Plus Panel with LevofloxacinDade Microscan, Inc.20024—
+1K983943Microstrep Plus Panel, LevofloxacinDade Microscan, Inc.20000—
+1K983953Microstrep Plus Panel, VancomycinDade Microscan, Inc.20000—
+1K993679Microstrep Plus Panel - Haemophilus/AmpicillinDade Microscan, Inc.20000—
+2K202423MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)Beckman Coulter, Inc.20210—
+2K111677Microscan (R) Microstrep Plus (R)Siemens Healthcare Diagnostics, Inc.20110—
+2K111205Microscan (R) Microstrep Plus (R) PanelsSiemens Healthcare Diagnostics, Inc.20110—
+2K111394Microscan MicrostepSiemens Healthcare Diagnostics, Inc.20110—
+2K063102Microscan Microstrep Plus Panel Cefaclor (0.5 - 8 MCG/ML)Dade Behring, Inc.20060—
+2K063101Microscan Microstrep Plus Panel Cefotaxime (0.015 - 8 MCG/MLDade Behring, Inc.20060—
+2K063099Microscan Microstrep Plus Panel Cefepime (O.015 - 8 MCG/ML)Dade Behring, Inc.20060—
+2K063065Microscan Microstrep Plus Panel Meropenem (0.03-4MCG/ML)Dade Behring, Inc.20060—
+2K063053Microscan Microstrep Plus Panel Cefuroxime (0.12-8 MCG/ML)Dade Behring, Inc.20060—
+2K063064Microscan Microstrep Plus Panel Ceftriaxone (0.015-8MCG/ML)Dade Behring, Inc.20060—
+2K062596Microstrep Plus Panel Amoxicillin/Clavulanic AcidDade Behring, Inc.20060—
+2K062585Microscan Microstrep Plus Panel AzithromycinDade Behring, Inc.20060—
+2K062290Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 MCG/ML)Dade Behring, Inc.20060—
+2K062276Microscan Microstrep Plus PanelDade Behring, Inc.20060—