SYNERMED ENZYMATIC CO2 REAGENT KIT— 510(k) K960793

Name: FDA 510(k) clearance K960793
Creator: U.S. Food and Drug Administration
Published: 1996-03-11

Substantially Equivalent

Synermed, Inc.

FDA 510(k) clearance K960793 for SYNERMED ENZYMATIC CO2 REAGENT KIT, Substantially Equivalent on 1996-03-11. Applicant: Synermed, Inc.. Device class: 2.

Clearance details

Applicant: Synermed, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1996-02-27
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

Download summary PDF View on FDA.gov ↗

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K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT1996-12-18

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