SYNERMED DIRECT BILIRUBIN REAGENT KIT— 510(k) K963939

Name: FDA 510(k) clearance K963939
Creator: U.S. Food and Drug Administration
Published: 1996-12-18

Substantially Equivalent

Synermed, Inc.

FDA 510(k) clearance K963939 for SYNERMED DIRECT BILIRUBIN REAGENT KIT, Substantially Equivalent on 1996-12-18. Applicant: Synermed, Inc.. Device class: 2.

Clearance details

Applicant: Synermed, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1996-10-01
Decision date: 1996-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

Download summary PDF View on FDA.gov ↗

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