QUICKPAC II ONE STEP OPIATES TEST— 510(k) K993491

Name: FDA 510(k) clearance K993491
Creator: U.S. Food and Drug Administration
Published: 1999-10-29

Substantially Equivalent

Syntron Bioresearch, Inc.

FDA 510(k) clearance K993491 for QUICKPAC II ONE STEP OPIATES TEST, Substantially Equivalent on 1999-10-29. Applicant: Syntron Bioresearch, Inc.. Device class: 2.

Clearance details

Applicant: Syntron Bioresearch, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1999-10-15
Decision date: 1999-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Simi Valley, CA, US

Download summary PDF View on FDA.gov ↗

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