DHX — System, Test, Carcinoembryonic Antigen Class II
FDA product code DHX covers "System, Test, Carcinoembryonic Antigen", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DHX
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223921 | beckman coulter | Access CEA | September 22, 2023 |
| K231517 | ortho clinical diagnostics | VITROS Immunodiagnostic Products CEA Reagent Pack | August 23, 2023 |
| K200215 | siemens healthcare disgnostics | ADVIA Centaur CEA Assay | April 13, 2020 |
| K081615 | olympus america | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | March 18, 2009 |
| K080194 | biomerieux | VIDAS CEA (S) ASSAY | October 9, 2008 |
| K071603 | dade behring | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | June 25, 2008 |
| K041322 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS | June 17, 2004 |
| K031270 | beckman coulter | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS | May 6, 2003 |
| K023893 | tosoh medics | ST AIA-PACK CEA ENZYME IMMUNOASSAY | December 18, 2002 |
| K013568 | bayer | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | December 21, 2001 |
| K991707 | beckman | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, | June 1, 1999 |
| K990943 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUC | June 1, 1999 |
| K990774 | abbott laboratories | ABBOTT ARCHITECT CEA | May 11, 1999 |
| K981985 | beckman coulter | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 | September 24, 1998 |
| K981478 | chiron diagnostics | ACS:CENTAUR CEA | August 12, 1998 |
| K980887 | boehringer mannheim | ELECSYS CEA ON THE ELECSYS 1010 | June 29, 1998 |
| K980855 | dpc cirrus | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | April 21, 1998 |
| K970877 | diagnostic products | IMMULITE CEA | September 22, 1997 |
| K924857 | tosoh medics | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | March 18, 1993 |
| K864877 | ciba corning diagnostics | TRI-LEVEL LIGAND CONTROL | May 21, 1987 |