Cleared Traditional

T-TEK

K050817 · R2 Diagnostics, Inc. · Hematology
Dec 2005
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K050817 is an FDA 510(k) clearance for the T-TEK, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on December 12, 2005, 256 days after receiving the submission on March 31, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K050817 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2005
Decision Date December 12, 2005
Days to Decision 256 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJA — Test, Thrombin Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7875

Similar Devices — GJA Test, Thrombin Time

All 19
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · Sigma Diagnostics, Inc. · Oct 1998
BC THROMBIN REAGENT
K970645 · Behring Diagnostics, Inc. · May 1997
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493 · Biomerieux Vitek, Inc. · Apr 1994
TEST THROMBIN
K930157 · Behring Diagnostics, Inc. · May 1993
THROMBIN CLOT TIME TEST PROCEDURE
K923220 · Medical Laboratory Automation Systems, Inc. · Sep 1992
THROMBIN CLOTTING TIME REAGENT
K920147 · Helena Laboratories · May 1992