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510(k) K050817

Device
T-TEK
Applicant
R2 DIAGNOSTICS, INC.
510(k) number
K050817
Product code
GJA  
Decision
Substantially Equivalent (SESE)
Decision date
2005-12-12
Date received
2005-03-31
Regulation
864.7875
Classification name
Test, Thrombin Time
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PEGGY S CARTER
Address
412 S. Lafayette Blvd. South Bend IN US 46601 46601

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GJA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K982209ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Sigma Diagnostics, Inc.1998-10-15
K970645BC THROMBIN REAGENTBehring Diagnostics, Inc.1997-05-19
K925493BIOMERIEUX HEMOLAB THROMBICALCI-TESTBiomerieux Vitek, Inc.1994-04-21
K930157TEST THROMBINBehring Diagnostics, Inc.1993-05-14
K923220THROMBIN CLOT TIME TEST PROCEDUREMedical Laboratory Automation Systems, Inc.1992-09-29
K920147THROMBIN CLOTTING TIME REAGENTHelena Laboratories1992-05-01
K900126TT AND HNTT BY HEMOCHRONInternational Technidyne Corp.1990-02-05
K894467THROMBIN TIME REAGENTSigma Chemical Co.1989-09-05
K884384THROMBIN-PREST REAGENT KITAmerican Bioproducts Co.1988-12-28
K884385FIBRI-PREST/THROMBIN-PREST CONTROLSAmerican Bioproducts Co.1988-12-28
K862301IL SYSTEM 810, ACL AND THE REAGENT SETSInstrumentation Laboratory CO1986-09-03
K845000THROMBINEX BOVINE THROMBINBio/Data Corp.1985-03-26
K841956BOVINE THROMBIN, HUMAN THROMBINHaemachem, Inc.1984-07-19
K834301THROMBOLYTIC ACTIVITY TESTBio/Data Corp.1984-02-04
K822466THROMBIN TIME TESTAmerican Dade1982-09-14

Legacy Summary#

summary

FDA Review#

Decision Summary