MICROLINE SCREEN FOR OPIATES— 510(k) K905491

Name: FDA 510(k) clearance K905491
Creator: U.S. Food and Drug Administration
Published: 1991-03-13

Substantially Equivalent

Drug Screening Systems, Inc.

FDA 510(k) clearance K905491 for MICROLINE SCREEN FOR OPIATES, Substantially Equivalent on 1991-03-13. Applicant: Drug Screening Systems, Inc.. Device class: 2.

Clearance details

Applicant: Drug Screening Systems, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1990-12-07
Decision date: 1991-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blackwood, NJ, US

Download summary PDF View on FDA.gov ↗

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