Mas Bilirubin Liquid Assayed Bilirubin Control

• • Terminated Z-1563-2013 FDA Class II ·initiated 13 May 2013

  It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

510(k) Number

K031890 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Medical Analysis Systems, Inc. →