DBEST OPIATES TEST KIT— 510(k) K983190

Substantially Equivalent

Ameritek, Inc.

FDA 510(k) clearance K983190 for DBEST OPIATES TEST KIT, Substantially Equivalent on 1998-11-18. Applicant: Ameritek, Inc.. Device class: 2.

Clearance details

Applicant: Ameritek, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1998-09-11
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.