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510(k) K811952

Device
AMES TDA CARBAMAZEPINE TEST
Applicant
MILES LABORATORIES, INC.
510(k) number
K811952
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-15
Date received
1981-07-07
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#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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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