Optigen Allergen Specific Ige Assay

• • Terminated Z-0793-2013 FDA Class III ·initiated 21 Dec 2012

  There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.

510(k) Number

K051677 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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