T-TEK

Test, Thrombin Time

R2 DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for T-tek.

Pre-market Notification Details

Device IDK050817
510k NumberK050817
Device Name:T-TEK
ClassificationTest, Thrombin Time
Applicant R2 DIAGNOSTICS, INC. 412 SOUTH LAFAYETTE BLVD. South Bend,  IN  46601
ContactPeggy S Carter
CorrespondentPeggy S Carter
R2 DIAGNOSTICS, INC. 412 SOUTH LAFAYETTE BLVD. South Bend,  IN  46601
Product CodeGJA  
CFR Regulation Number864.7875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-31
Decision Date2005-12-12
Summary:summary

Trademark Results [T-TEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T-TEK
T-TEK
87441227 5291182 Live/Registered
T-Tek LLC
2017-05-08
T-TEK
T-TEK
87360511 5290976 Live/Registered
T-Tek LLC
2017-03-06
T-TEK
T-TEK
75160141 2246396 Dead/Cancelled
NEWCO RESEARCH CORPORATION
1996-09-04
T-TEK
T-TEK
75068987 2104739 Dead/Cancelled
Mohawk Carpet Corporation
1996-03-07
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