510(k) K024339

Device
COZART EIA OPIATES ORAL FLUID KIT
Applicant
COZART BIOSCIENCE LTD.
510(k) number
K024339
Product code
DIG  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-07
Date received
2002-12-27
Regulation
862.3240
Classification name
Cholinesterase Test Paper
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERTO LIDDI
Address
45 Milton Park Abingdon Oxfordshire Ox14 4ru GB OX14 4RU OX14 4RU

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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