SYNCHRON SYSTEMS METHADONE REAGENT— 510(k) K973069

Name: FDA 510(k) clearance K973069
Creator: U.S. Food and Drug Administration
Published: 1997-09-22

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K973069 for SYNCHRON SYSTEMS METHADONE REAGENT, Substantially Equivalent on 1997-09-22. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DJR
Device class: Class 2
Regulation: 21 CFR 862.3620
Advisory panel: Clinical Toxicology
Date received: 1997-08-18
Decision date: 1997-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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