Tri-Level Ligand Control
FDA 510(k) K864877 · Ciba Corning Diagnostics Corp.
510(k) numberK864877
Submission
- Device name
- Tri-Level Ligand Control
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- December 12, 1986
- Decision date
- May 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHX – System, Test, Carcinoembryonic Antigen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code DHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223921 | Access CEADHX · Traditional | Beckman Coulter, Inc. | 09/22/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | Ortho Clinical Diagnostics | 08/23/2023SE |
| K200215 | ADVIA Centaur CEA AssayDHX · Traditional | Siemens Healthcare Disgnostics, Inc. | 04/13/2020SE |
| K081615 | Olympus Cea - Carcinoembryonic AntigenDHX · Traditional | Olympus America, Inc. | 03/18/2009SE |
| K080194 | Vidas Cea (S) AssayDHX · Traditional | bioMerieux, Inc. | 10/09/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | Dade Behring, Inc. | 06/25/2008SE |
| K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersDHX · Special | Ortho-Clinical Diagnostics, Inc. | 06/17/2004SE |
| K031270 | Access Cea Reagents for Use on the Access Immunoassay SystemsDHX · Special | Beckman Coulter, Inc. | 05/06/2003SE |
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | Tosoh Medics, Inc. | 12/18/2002SE |
| K013568 | Cea Assay for the Advia Integrated Modular SystemDHX · Traditional | Bayer Corp. | 12/21/2001SE |
More from Bayer Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Tri-Level Ligand Control cleared by the FDA?
Tri-Level Ligand Control (K864877) received a 510(k) decision of Substantially Equivalent on May 21, 1987, 160 days after the submission was received.
What is the product code of K864877?
The FDA product code is DHX – System, Test, Carcinoembryonic Antigen, a Class II (moderate risk) device regulated under 21 CFR 866.6010.