SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT— 510(k) K051307

Name: FDA 510(k) clearance K051307
Creator: U.S. Food and Drug Administration
Published: 2005-06-13

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K051307 for SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT, Substantially Equivalent on 2005-06-13. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 2005-05-19
Decision date: 2005-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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