OPIATE EIA ASSAY— 510(k) K915180

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K915180 for OPIATE EIA ASSAY, Substantially Equivalent on 1992-01-22. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1991-11-15
Decision date: 1992-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.