Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution

• • Terminated Z-1412-2021 FDA Class II ·initiated 18 Feb 2021

  Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

• • Terminated Z-1831-2013 FDA Class II ·initiated 30 Apr 2013 ·on shared 510(k) K100464

  Product fails to meet the accuracy at the low end of the measuring range.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K100464 ↗

FDA Product Code

NSF

Device Class

Class II

Regulation

21 CFR Part 866.6030

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Wako Chemicals USA, Inc. →