Amicon Ultrafiltration Membranes Cmii
FDA 510(k) K810810 · Amicon, Inc.
510(k) numberK810810
Submission
- Device name
- Amicon Ultrafiltration Membranes Cmii
- Applicant
- Amicon, Inc.
Mchenry, IL, US - Received
- March 24, 1981
- Decision date
- April 17, 1981
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K930168 | Centricon -50 ConcentratorJJH · Traditional | 08/05/1993SE |
| K902837 | Amicon Diafilter 30 HemoconcentratorKDI · Traditional | 11/01/1990SE |
| K901286 | Amicon Hemoconcentrator SetKDI · Traditional | 05/18/1990SE |
| K900280 | Centriprep 100JJP · Traditional | 02/16/1990SE |
| K895405 | Amicon Minifilter Plus HemofilterKDI · Traditional | 01/11/1990SE |
| K893733 | Centricon ConcentratorJJH · Traditional | 07/20/1989SE |
| K892645 | Amicon Vitafiber Flo-Path Biorect/Vls Cell Cult SyKJF · Traditional | 06/13/1989SE |
| K875121 | Amicon Equaline Fluid Balance SystemKPF · Traditional | 02/19/1988SE |
| K870690 | Centriprep ConcentratorJJH · Traditional | 03/19/1987SE |
| K863823 | Amicon Diafilter HemofilterKDI · Traditional | 11/06/1986SE |
Questions and answers
When was Amicon Ultrafiltration Membranes Cmii cleared by the FDA?
Amicon Ultrafiltration Membranes Cmii (K810810) received a 510(k) decision of Substantially Equivalent on April 17, 1981, 24 days after the submission was received.
What is the product code of K810810?
The FDA product code is DHX – System, Test, Carcinoembryonic Antigen, a Class II (moderate risk) device regulated under 21 CFR 866.6010.