MICRO EIA FOR AMPHETAMINE METABOLITES— 510(k) K932304

Name: FDA 510(k) clearance K932304
Creator: U.S. Food and Drug Administration
Published: 1993-12-07

Substantially Equivalent

Microdiagnostics, Inc.

FDA 510(k) clearance K932304 for MICRO EIA FOR AMPHETAMINE METABOLITES, Substantially Equivalent on 1993-12-07. 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: 1993-05-12
Decision date: 1993-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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