510(k) K983151— IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT

Substantially Equivalent

Beckman Coulter, Inc.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1998-09-09
Decision date: 1998-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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