Diastat Anti-Thyroglobulin Kit

• • Terminated Z-0675-05 FDA Unclassified (pre-2012) ·initiated 12 Apr 2004

  The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.

510(k) Number

K952183 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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