Innofluor (Tm) Tobramycin Calibrator Set

• • Terminated Z-0773-2012 FDA Unclassified (pre-2012) ·initiated 11 Nov 2011

  Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range.

510(k) Number

K872349 ↗

FDA Product Code

DLJ

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Innotron of Oregon, Inc. →