CEDIA DAU AMPHETAMINES/ECSTASY ASSAY— 510(k) K010496

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K010496 for CEDIA DAU AMPHETAMINES/ECSTASY ASSAY, Substantially Equivalent on 2001-05-29. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant
Microgenics Corp.
Product code
Code LAF
Device class
Class 2
Regulation
21 CFR 862.3610
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fremont Blvd., CA, US
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