DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS— 510(k) K081378

Clearance details

Applicant

Thermo Fisher Scientific

Product code

Code DJR

Device class

Class 2

Regulation

21 CFR 862.3620

Advisory panel

Clinical Toxicology

Date received

2008-05-16

Decision date

2009-01-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fremont Blvd., CA, US

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