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510(k) K223078

Device
Atellica® CH Diazo Direct Bilirubin (D_DBil)
Applicant
Siemens Healthcare Diagnostics, Inc.
510(k) number
K223078
Product code
CIG
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-12
Date received
2022-09-30
Regulation
862.1110
Classification name
Diazo Colorimetry, Bilirubin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anthony Calabro
Address
500 Gbc Dr., M/S 514, P.O. Box 6101 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CIG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.2026-02-27
K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.2023-03-20
K223324Total Bilirubin2Abbott Ireland Diagnostics Division2022-12-29
K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.2019-04-26
K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup2017-07-11
K150510Total BilirubinAbbott Laboratories2015-04-02
K131544COBAS C BILIRUBIN TOTAL GEN.3Roche Diagnostics2013-07-17
K131217S TEST REAGENT CARTRIDGE TOTAL BILIRUBINHitachi Chemical Diagnostics, Inc.2013-06-07
K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTMedica Corp.2013-03-01
K123965COBAS INTEGRA BILIRUBIN DIRECT GEN.2Roche Diagnostics2013-02-28
K121985ARCHITECT TOTAL BILIRUBINAbbott Laboratories2013-02-01
K110780ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & IIElitechgroup2011-10-07
K111143POLY-CHEM 90 TOTAL BILIRUBINPolymedco, Inc.2011-09-01
K093623GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TOInstrumentation Laboratory CO2010-06-18
K091991EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200Medica Corp.2009-09-04