Diastat Anti-Mitochondrial Antibody Kit

• • Terminated Z-0673-05 FDA Unclassified (pre-2012) ·initiated 12 Apr 2004

  The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.

510(k) Number

K921183 ↗

FDA Product Code

DBM

Device Class

Class II

Regulation

21 CFR Part 866.5090

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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