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510(k) K860047

Device
DETERMINATION OF CARBAMAZEPINE
Applicant
CLINICAL DATA, INC.
510(k) number
K860047
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-22
Date received
1986-01-06
Regulation
862.3645
Classification name
Enzyme Immunoassay, Carbamazepine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ISRAEL M STEIN,M.D.
Address
1172 Commonwealth Ave. Boston MA US 02134 02134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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