SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT— 510(k) K973109

Substantially Equivalent

Synermed, Inc.

FDA 510(k) clearance K973109 for SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT, Substantially Equivalent on 1997-09-25. Applicant: Synermed, Inc..

Clearance details

Applicant: Synermed, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1997-08-19
Decision date: 1997-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

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