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510(k) K935307

Device
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
Applicant
BAXTER DIAGNOSTICS, INC.
510(k) number
K935307
Product code
DDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-22
Date received
1993-11-02
Regulation
864.7060
Classification name
Antigen, Antiserum, Control, Antithrombin Iii
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RADAMES RIESGO
Address
P.O.Box 520672 Miami FL US 33152 33152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DDQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972257N-ASSAY TIA ANTITHROMBIN III TEST KITCrestat Diagnostics, Inc.1997-10-20
K932713TRACE TRANSFERRIN REAGENTTrace Scientific , Ltd.1993-09-30
K780012ANTITHROMBIN III RIARia Diagnostics1978-01-20

Legacy Summary#

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FDA Review#

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