Cleared Traditional

K030845 - COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING (FDA 510(k) Clearance)

K030845 · Roche Diagnostics Corp. · Hematology device

May 2003

Decision

66d

Days

Class 2

Risk

K030845 is an FDA 510(k) clearance for the COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 22, 2003, 66 days after receiving the submission on March 17, 2003.

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

Submission Details

510(k) Number	K030845 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 2003
Decision Date	May 22, 2003
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF