Dsl Active Androstenedione Ria (Dsl #3800)

• • Terminated Z-0634-05 FDA Unclassified (pre-2012) ·initiated 15 Jul 2004

  Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.

• • Terminated Z-0704-05 FDA Unclassified (pre-2012) ·initiated 25 May 2004

  Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.

510(k) Number

K854650 ↗

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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