Cleared Traditional

COAGUCHEK XS PLUS PST SYSTEM

K092940 · Roche Diagnostics Corp. · Hematology
Mar 2010
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K092940 is an FDA 510(k) clearance for the COAGUCHEK XS PLUS PST SYSTEM, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on March 5, 2010, 162 days after receiving the submission on September 24, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K092940 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2009
Decision Date March 05, 2010
Days to Decision 162 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750