MICRO EIA FOR OPIATE METABOLITES— 510(k) K923468

Name: FDA 510(k) clearance K923468
Creator: U.S. Food and Drug Administration
Published: 1992-09-15

Substantially Equivalent

Microdiagnostics, Inc.

FDA 510(k) clearance K923468 for MICRO EIA FOR OPIATE METABOLITES, Substantially Equivalent on 1992-09-15. 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: 1992-07-14
Decision date: 1992-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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