Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent

FDA 510(k) K981632 · Roche Diagnostics/Boehringer Mannheim GmbH

Substantially Equivalent

510(k) numberK981632

Submission

Device name
Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent
Applicant
Roche Diagnostics/Boehringer Mannheim GmbH
Indianapolis, IN, US
Received
May 8, 1998
Decision date
June 15, 1998
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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K223324Total Bilirubin2CIG · Traditional Abbott Ireland Diagnostics Division12/29/2022SE
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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
K131217S Test Reagent Cartridge Total BilirubinCIG · Traditional Hitachi Chemical Diagnostics, Inc.06/07/2013SE
K123802Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional Medica Corp.03/01/2013SE

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Questions and answers

When was Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent cleared by the FDA?

Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent (K981632) received a 510(k) decision of Substantially Equivalent on June 15, 1998, 38 days after the submission was received.

What is the product code of K981632?

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