Biotrack Protime Controls (Biotrack Protime Test)

• • Terminated Z-0814-03 FDA Unclassified (pre-2012) ·initiated 12 Mar 2003

  High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

510(k) Number

K860719 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Biotrack, Inc. →