SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT— 510(k) K983304

Substantially Equivalent

Synermed Intl., Inc.

FDA 510(k) clearance K983304 for SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT, Substantially Equivalent on 1998-11-04. Applicant: Synermed Intl., Inc..

Clearance details

Applicant: Synermed Intl., Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1998-09-21
Decision date: 1998-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine, Quebec, CA

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