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510(k) K000007

Device
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
Applicant
DIAGNOSTIC PRODUCTS CORP.
510(k) number
K000007
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-28
Date received
2000-01-03
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
EDWARD M LEVINE
Address
5700 W. 96th St. Los Angeles CA US 90045 90045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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