Quantase Phenylalanine Assay

• • Terminated Z-1562-2011 FDA Unclassified (pre-2012) ·initiated 26 Jan 2010

  Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

510(k) Number

K961515 ↗

FDA Product Code

JNB

Device Class

Class II

Regulation

21 CFR Part 862.1555

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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