Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254

• • Ongoing Z-0924-2018 FDA Class II ·initiated 10 Nov 2017

  Internal program testing shows that product may not reach the indicated expiration date.

510(k) Number

K023889 ↗

FDA Product Code

MIU

Device Class

Class I

Regulation

21 CFR Part 866.3870

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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