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510(k) K010814

Device
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
Applicant
SYVA CO., DADE BEHRING, INC.
510(k) number
K010814
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-13
Date received
2001-03-19
Regulation
862.3645
Classification name
Enzyme Immunoassay, Carbamazepine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VIRGINIA SINGER
Address
P.O. Box 49013 3403 Yerba Buena Rd. San Jose CA US 95135 95135

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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