Synermedir Cal I and Synermed Ir Cal II

FDA 510(k) K940571 · Synermed, Inc.

Substantially Equivalent

510(k) numberK940571

Submission

Device name
Synermedir Cal I and Synermed Ir Cal II
Applicant
Synermed, Inc.
Quebec, Canada, CA
Received
February 8, 1994
Decision date
April 21, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JIX – Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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K962479Synermed Ise ReagentsCGZ · Traditional 03/03/1997SE
K963939Synermed Direct Bilirubin Reagent KitCIG · Traditional 12/18/1996SE
K960793Synermed Enzymatic CO2 Reagent KitKHS · Traditional 03/11/1996SE
K953395Synermed Calcium Reagent KitCJY · Traditional 08/31/1995SE
K952179Synermed Ise ReagentsJGS · Traditional 06/20/1995SE
K943924Creatinine-Po Reagent KitCGX · Traditional 09/20/1994SE
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Questions and answers

When was Synermedir Cal I and Synermed Ir Cal II cleared by the FDA?

Synermedir Cal I and Synermed Ir Cal II (K940571) received a 510(k) decision of Substantially Equivalent on April 21, 1994, 72 days after the submission was received.

What is the product code of K940571?

The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.