Cleared Traditional

K060978 - COAGUCHEK XS SYSTEM (FDA 510(k) Clearance)

K060978 · Roche Diagnostics · Hematology device

Aug 2006

Decision

123d

Days

Class 2

Risk

K060978 is an FDA 510(k) clearance for the COAGUCHEK XS SYSTEM. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 11, 2006, 123 days after receiving the submission on April 10, 2006.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number	K060978 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 10, 2006
Decision Date	August 11, 2006
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF