Synermed Total Bilirubin Reagent Kit

FDA 510(k) K940570 · Synermed, Inc.

Substantially Equivalent

510(k) numberK940570

Submission

Device name
Synermed Total Bilirubin Reagent Kit
Applicant
Synermed, Inc.
Quebec, Canada, CA
Received
February 8, 1994
Decision date
April 20, 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
CIG – Diazo Colorimetry, Bilirubin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1110
Specialty
Clinical Chemistry

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K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional Elitechgroup07/11/2017SE
K150510Total BilirubinCIG · Traditional Abbott Laboratories04/02/2015SE
K131544Cobas C Bilirubin Total GEN.3CIG · Traditional Roche Diagnostics07/17/2013SE
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More from Medica Corp.

510(k)DeviceDecision
K973109Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional 09/25/1997SE
K972716Synermed Total Bilirubin Reagent KitCIG · Traditional 08/07/1997SE
K971491Synermed Ir 200 Chemistry AnalyzerJJF · Traditional 06/26/1997SE
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
K941091Synermed Amylase Reagent KitJFJ · Traditional 05/03/1994SE

Questions and answers

When was Synermed Total Bilirubin Reagent Kit cleared by the FDA?

Synermed Total Bilirubin Reagent Kit (K940570) received a 510(k) decision of Substantially Equivalent on April 20, 1994, 71 days after the submission was received.

What is the product code of K940570?

The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.