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510(k) K940374

Device
QMS CARBAMAZEPINE ASSAY
Applicant
SERADYN, INC.
510(k) number
K940374
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-02
Date received
1994-01-26
Regulation
862.3645
Classification name
Enzyme Immunoassay, Carbamazepine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANDRIS INDRIKSONS, PH.D.
Address
P.O. Box 1210 Indianapolis IN US 46206 46206

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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