510(k) Report

Devices descending from K902154

9 later devices reach NA Latex Myoglobin Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042982Quantex MyoglobinInstrumentation Laboratory CO20040—
+1K973358Myoglobin Control SetBoehringer Mannheim Corp.19971—
+1K972513Tinaquant Myoglobin AssayBoehringer Mannheim Corp.19974—
+1K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.199612
+2K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories20130—
+2K061683Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp.200611
+2K031650Ferritin Generation 2Roche Diagnostics Corp.20030—
+2K983176Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp.19981—
+3K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics20090—