Coat-A-Count Direct Androstenedione

• • Terminated Z-2058-2014 FDA Class II ·initiated 9 Jun 2014

  The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

510(k) Number

K954755 ↗

FDA Product Code

CIZ

Device Class

Class I

Regulation

21 CFR Part 862.1075

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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