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510(k) K942687

Device
IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K942687
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-25
Date received
1994-06-07
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
WALLIS W CADY
Address
101 Hartwell Ave. Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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