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

Name: FDA 510(k) clearance K983304
Creator: U.S. Food and Drug Administration
Published: 1998-11-04

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.. Device class: 2.

Clearance details

Applicant: Synermed Intl., Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1998-09-21
Decision date: 1998-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine, Quebec, CA

Download summary PDF View on FDA.gov ↗

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