Clinetics Pca Column
FDA 510(k) K801306 · Clinetics Corp.
510(k) numberK801306
Submission
- Device name
- Clinetics Pca Column
- Applicant
- Clinetics Corp.
Mchenry, IL, US - Received
- June 3, 1980
- Decision date
- September 26, 1980
- 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 |
|---|---|---|
| K862180 | Modified Cotropin Radioimmunoassay KitCEP · Traditional | 07/07/1986SE |
| K844066 | Cotropin Stimulataneous 57 Co-Lh 125I I-FshCGJ · Traditional | 01/18/1985SE |
| K841580 | TSH Receptor Antibody Kit 125I TSHJZO · Traditional | 10/22/1984SE |
| K833934 | Adrenocorticotropic Hormone TestCKG · Traditional | 04/04/1984SE |
| K830357 | Radioimmunoassay Immunoglobulins D.EDGC · Traditional | 03/17/1983SE |
| K823380 | 125-I LH Radioimmunoassay KitCEP · Traditional | 12/22/1982SE |
| K823379 | 125-I FSH Radioimmunoassay KitCGJ · Traditional | 12/22/1982SE |
| K822152 | HCG Beta Ria KitJHI · Traditional | 09/02/1982SE |
Questions and answers
When was Clinetics Pca Column cleared by the FDA?
Clinetics Pca Column (K801306) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 115 days after the submission was received.
What is the product code of K801306?
The FDA product code is DHX – System, Test, Carcinoembryonic Antigen, a Class II (moderate risk) device regulated under 21 CFR 866.6010.