COCAINE METABOLITE EIA TEST— 510(k) K960187

Clearance details

Applicant

Diagnostic Reagents, Inc.

Product code

Code DIO

Device class

Class 2

Regulation

21 CFR 862.3250

Advisory panel

Clinical Toxicology

Date received

1996-01-16

Decision date

1996-04-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunnyvale, CA, US

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• K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS1998-11-05

• Z-2267-2013 — DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.Class II·Terminated·Microgenics Corp·20130723

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960187.