IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)— 510(k) K041746

Name: FDA 510(k) clearance K041746
Creator: U.S. Food and Drug Administration
Published: 2004-11-23

Substantially Equivalent

Lifepoint,Inc

FDA 510(k) clearance K041746 for IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE), Substantially Equivalent on 2004-11-23. Applicant: Lifepoint,Inc. Device class: 2.

Clearance details

Applicant: Lifepoint,Inc
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2004-06-29
Decision date: 2004-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, CA, US

Download summary PDF View on FDA.gov ↗

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