ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE— 510(k) K010841

Name: FDA 510(k) clearance K010841
Creator: U.S. Food and Drug Administration
Published: 2001-07-09

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K010841 for ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE, Substantially Equivalent on 2001-07-09. Applicant: ACON Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2001-03-21
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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