Coaguchek System

• • Terminated Z-0099-06 FDA Unclassified (pre-2012) ·initiated 28 Mar 2005 ·on shared 510(k) K952625

  Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

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

510(k) Number

K952625 ↗

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 Boehringer Mannheim Corp. →