510(k) K981985
- Device
- ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K981985
- Product code
- DHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-24
- Date received
- 1998-06-05
- Regulation
- 866.6010
- Classification name
- System, Test, Carcinoembryonic Antigen
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELLEN M VOSS
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 3006198300
- 3005360469
- 3005333358
- 2432235
- 3012963943
- 2250051
- 3008344661
- 3002809144
- 9612316
- 2020726
- 1036362
- 2517506
- 2122870
- 8031673
- 3011989923
- 3002642396
- 8020888
- 8023060
- 1219913
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3000308930
- 3002806944
- 2032839
Source Documents#
Other 510(k) Records For Product Code DHX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223921 | Access CEA | Beckman Coulter, Inc. | 2023-09-22 |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | 2023-08-23 |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | 2020-04-13 |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Olympus America, Inc. | 2009-03-18 |
| K080194 | VIDAS CEA (S) ASSAY | bioMerieux, Inc. | 2008-10-09 |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Dade Behring, Inc. | 2008-06-25 |
| K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2004-06-17 |
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2003-05-06 |
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-18 |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Corp. | 2001-12-21 |
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 | Beckman | 1999-06-01 |
| K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 |
| K990774 | ABBOTT ARCHITECT CEA | Abbott Laboratories | 1999-05-11 |
| K981478 | ACS:CENTAUR CEA | Chiron Diagnostics Corp. | 1998-08-12 |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-06-29 |
Legacy Summary#
summary
FDA Review#
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