SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT— 510(k) K043556

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K043556 for SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT, Substantially Equivalent on 2005-03-28. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
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