SYNCHRON SYSTEMS OPIATE REAGENT— 510(k) K031002

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K031002 for SYNCHRON SYSTEMS OPIATE REAGENT, Substantially Equivalent on 2003-04-29. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2003-03-31
Decision date: 2003-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

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