ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC— 510(k) K060810

Name: FDA 510(k) clearance K060810
Creator: U.S. Food and Drug Administration
Published: 2006-08-07

Substantially Equivalent

Ind Diagnostic, Inc.

FDA 510(k) clearance K060810 for ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC, Substantially Equivalent on 2006-08-07. Applicant: Ind Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Ind Diagnostic, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2006-03-24
Decision date: 2006-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

Download summary PDF View on FDA.gov ↗

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