FDA.reportPublic FDA data

510(k) K080810

Device
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
Applicant
MEDICA CORP.
510(k) number
K080810
Product code
CIG  
Decision
Substantially Equivalent (SESE)
Decision date
2008-12-10
Date received
2008-03-21
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
Photios Makris
Address
5 Oak Park Dr. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.2023-06-12
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

Legacy Summary#

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FDA Review#

Decision Summary