CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS— 510(k) K944604

Name: FDA 510(k) clearance K944604
Creator: U.S. Food and Drug Administration
Published: 1994-12-07

Substantially Equivalent

Beckman-Diagnostic Systems Group

FDA 510(k) clearance K944604 for CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS, Substantially Equivalent on 1994-12-07. Applicant: Beckman-Diagnostic Systems Group. Device class: 2.

Clearance details

Applicant: Beckman-Diagnostic Systems Group
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1994-09-19
Decision date: 1994-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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