MICRO-STRIP FOR OPIATE METABOLITES— 510(k) K973761

Name: FDA 510(k) clearance K973761
Creator: U.S. Food and Drug Administration
Published: 1997-12-24

Substantially Equivalent

Microdiagnostics, Inc.

FDA 510(k) clearance K973761 for MICRO-STRIP FOR OPIATE METABOLITES, Substantially Equivalent on 1997-12-24. Applicant: Microdiagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Microdiagnostics, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1997-10-02
Decision date: 1997-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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