QUIKPAC II ONE STEP OPIATE TEST— 510(k) K972405

Name: FDA 510(k) clearance K972405
Creator: U.S. Food and Drug Administration
Published: 1997-08-08

Substantially Equivalent

Drial Consultants, Inc.

FDA 510(k) clearance K972405 for QUIKPAC II ONE STEP OPIATE TEST, Substantially Equivalent on 1997-08-08. Applicant: Drial Consultants, Inc.. Device class: 2.

Clearance details

Applicant: Drial Consultants, Inc.
Product code: Product code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1997-06-26
Decision date: 1997-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Simi Valley, CA, US

Download summary PDF View on FDA.gov ↗

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