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510(k) K972257

Device
N-ASSAY TIA ANTITHROMBIN III TEST KIT
Applicant
CRESTAT DIAGNOSTICS, INC.
510(k) number
K972257
Product code
DDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-20
Date received
1997-06-17
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARY REES
Address
374 Goodhill Rd. Weston CT US 06883 06883

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DDQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935307DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISABaxter Diagnostics, Inc.1994-11-22
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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