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510(k) K925452

Device
DADE HEPZYME
Applicant
BAXTER DIAGNOSTICS, INC.
510(k) number
K925452
Product code
JBR  
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-11
Date received
1992-10-28
Regulation
864.7525
Classification name
Test, Heparin Neutralization
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARLA ISSITT
Address
1851 Delaware Pkwy. Miami FL US 33125 33125

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874373PT PRO-CLOTProbe-Tek, Inc.1988-01-05
K770722THROMBO SCREEN QUANTITATIVE HEPARIN ASSABay Area Hema. Onco. Clinic. & Res. L1977-07-11

Legacy Summary#

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FDA Review#

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