Rianen Angiotensin I Radioimmunoassay Ki

• 2 recalls, same reason

  • Terminated Z-1206-03 FDA Unclassified (pre-2012) ·initiated 28 Jul 2003
  • Terminated Z-1207-03 FDA Unclassified (pre-2012) ·initiated 28 Jul 2003

  Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples

510(k) Number

K850054 ↗

FDA Product Code

CIB

Device Class

Class II

Regulation

21 CFR Part 862.1085

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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