MICRO-STRIP FOR AMPHETAMINE METABOLITES— 510(k) K974611

Name: FDA 510(k) clearance K974611
Creator: U.S. Food and Drug Administration
Published: 1998-03-20

Substantially Equivalent

Microdiagnostics, Inc.

FDA 510(k) clearance K974611 for MICRO-STRIP FOR AMPHETAMINE METABOLITES, Substantially Equivalent on 1998-03-20. Applicant: Microdiagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Microdiagnostics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1997-12-11
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, 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.