Atlas FDA

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK

FDA 510(k) clearance K990943 · decided 1999-06-01

Clearance details

K-number
K990943
Device name
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1999-03-22
Decision date
1999-06-01
Days to decision
71 days
Clearance type
Traditional
Product code
DHX
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access CEA (K223921)Beckman Coulter, Inc.2023-09-22
VITROS Immunodiagnostic Products CEA Reagent Pack (K231517)Ortho Clinical Diagnostics2023-08-23
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
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 Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19