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510(k) K000903

Device
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
Applicant
BAYER CORP.
510(k) number
K000903
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-18
Date received
2000-03-21
Regulation
862.3645
Classification name
Enzyme Immunoassay, Carbamazepine
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FREDRICK CLERIE
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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