510(k) K904413

Device
Cedia(tm) Phenobarbital Assay
Applicant
MICROGENICS CORP.
510(k) number
K904413
Product code
LAF
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-05
Date received
1990-09-26
Regulation
862.3610
Classification name
Gas Chromatography, Methamphetamine
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Contact
Patricia M Klimley
Address
2380a Bisso Ln. Concord CA US 94520 94520

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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Primary DIBrandCompanyPublished
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