Atlas FDA

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k) clearance K231517 · decided 2023-08-23

Clearance details

K-number
K231517
Device name
VITROS Immunodiagnostic Products CEA Reagent Pack
Applicant
Ortho Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2023-05-25
Decision date
2023-08-23
Days to decision
90 days
Clearance type
Traditional
Product code
DHX
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Bridgend, GB
Third-party review
No
Expedited review
No

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RecordFirmDate
Access CEA (K223921)Beckman Coulter, Inc.2023-09-22
ADVIA Centaur CEA Assay (K200215)Siemens Healthcare Disgnostics, Inc.2020-04-13
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (K081615)Olympus America, Inc.2009-03-18
VIDAS CEA (S) ASSAY (K080194)bioMerieux, Inc.2008-10-09
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (K071603)Dade Behring, Inc.2008-06-25
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322)Ortho-Clinical Diagnostics, Inc.2004-06-17
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270)Beckman Coulter, Inc.2003-05-06
ST AIA-PACK CEA ENZYME IMMUNOASSAY (K023893)Tosoh Medics, Inc.2002-12-18
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K013568)Bayer Corp.2001-12-21
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 (K991707)Beckman1999-06-01
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943)Ortho-Clinical Diagnostics, Inc.1999-06-01
ABBOTT ARCHITECT CEA (K990774)Abbott Laboratories1999-05-11

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02