Bd Microtainer Map Microtube for Automated Process, Model 363706

• • Terminated Z-0176-2012 FDA Unclassified (pre-2012) ·initiated 11 Feb 2011

  BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.

510(k) Number

K093972 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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