CEA DESALTING DOLUMN SEPHADEX R
FDA 510(k) clearance K811394 · decided 1981-06-12
Clearance details
- K-number
- K811394
- Device name
- CEA DESALTING DOLUMN SEPHADEX R
- Applicant
- Immuno-Diagnostic Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-05-18
- Decision date
- 1981-06-12
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, 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.
| Record | Firm | Date |
|---|
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| VITROS Immunodiagnostic Products CEA Reagent Pack (K231517) | Ortho Clinical Diagnostics | 2023-08-23 |
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| 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) | Beckman | 1999-06-01 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943) | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 |
Recalls involving this device
No recalls on record reference this clearance.