ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

FDA 510(k) K171401 · Elitechgroup

Substantially Equivalent

510(k) numberK171401

Submission

Device name
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
Applicant
Elitechgroup
Sees, FR
Received
May 12, 2017
Decision date
July 11, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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K222104Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional Siemens Healthcare Diagnostics, Inc.03/20/2023SE
K223324Total Bilirubin2CIG · Traditional Abbott Ireland Diagnostics Division12/29/2022SE
K190807VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional Ortho-Clinical Diagnostics, Inc.04/26/2019SE
K150510Total BilirubinCIG · Traditional Abbott Laboratories04/02/2015SE
K131544Cobas C Bilirubin Total GEN.3CIG · Traditional Roche Diagnostics07/17/2013SE
K131217S Test Reagent Cartridge Total BilirubinCIG · Traditional Hitachi Chemical Diagnostics, Inc.06/07/2013SE
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K123965Cobas Integra Bilirubin Direct GEN.2CIG · Traditional Roche Diagnostics02/28/2013SE

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Questions and answers

When was ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 cleared by the FDA?

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (K171401) received a 510(k) decision of Substantially Equivalent on July 11, 2017, 60 days after the submission was received.

What is the product code of K171401?

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