FDA Product Code
FDA Product Code DHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223921 | Access CEA | Beckman Coulter, Inc. | 2023-09-22 | Traditional | PDF ↗ |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | 2023-08-23 | Traditional | PDF ↗ |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | 2020-04-13 | Traditional | PDF ↗ |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Olympus America, Inc. | 2009-03-18 | Traditional | PDF ↗ |
| K080194 | VIDAS CEA (S) ASSAY | bioMerieux, Inc. | 2008-10-09 | Traditional | PDF ↗ |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Dade Behring, Inc. | 2008-06-25 | Traditional | PDF ↗ |
| K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2004-06-17 | Special | PDF ↗ |
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2003-05-06 | Special | PDF ↗ |
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-18 | Special | PDF ↗ |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Corp. | 2001-12-21 | Traditional | PDF ↗ |
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 | Beckman | 1999-06-01 | Special | PDF ↗ |
| K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K990774 | ABBOTT ARCHITECT CEA | Abbott Laboratories | 1999-05-11 | Traditional | PDF ↗ |
| K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 | Beckman Coulter, Inc. | 1998-09-24 | Traditional | PDF ↗ |
| K981478 | ACS:CENTAUR CEA | Chiron Diagnostics Corp. | 1998-08-12 | Traditional | PDF ↗ |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-06-29 | Traditional | PDF ↗ |
| K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | Dpc Cirrus | 1998-04-21 | Traditional | PDF ↗ |
| K970877 | IMMULITE CEA | Diagnostic Products Corp. | 1997-09-22 | Traditional | PDF ↗ |
| K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K864877 | TRI-LEVEL LIGAND CONTROL | Ciba Corning Diagnostics Corp. | 1987-05-21 | Traditional | PDF ↗ |
| K833318 | NORMAL GOAT SERUM | Biosan Laboratories, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K820298 | CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV | Ventrex Laboratories, Inc. | 1982-04-08 | Traditional | PDF ↗ |
| K812658 | CEA CONTROL PLASMA | Pacific Hemostasis | 1981-09-29 | Traditional | PDF ↗ |
| K810459 | THREE LEVEL CONTROL SERA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-03 | Traditional | PDF ↗ |
| K811394 | CEA DESALTING DOLUMN SEPHADEX R | Immuno-Diagnostic Laboratories | 1981-06-12 | Traditional | PDF ↗ |
| K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII | Amicon, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K801306 | CLINETICS PCA COLUMN | Clinetics Corp. | 1980-09-26 | Traditional | PDF ↗ |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Environmental Chemical Specialties | 1980-09-26 | Traditional | PDF ↗ |
Product code DHX · Class II · Immunology. Data: openFDA.