Cleared Traditional

K020831 - PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 (FDA 510(k) Clearance)

K020831 · Roche Diagnostics Corp. · Hematology device

Oct 2002

Decision

224d

Days

Class 2

Risk

K020831 is an FDA 510(k) clearance for the PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404. 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 October 24, 2002, 224 days after receiving the submission on March 14, 2002.

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

Submission Details

510(k) Number	K020831 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 2002
Decision Date	October 24, 2002
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF