Coaguchek System

• • Terminated Z-0099-06 FDA Unclassified (pre-2012) ·initiated 28 Mar 2005

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

510(k) Number

K942884 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Precimat Glycerol

  Class I

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  Class II

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• Stattek Bun

  Class II

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  Class II

  FDA 510(k) K931258 Active Cleared 10 Feb 1994

See all devices from Boehringer Mannheim Corp. →