Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206
FDA 510(k) K991707 · Beckman
510(k) numberK991707
Submission
- Device name
- Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206
- Applicant
- Beckman
Chaska, MN, US - Received
- May 19, 1999
- Decision date
- June 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K971534 | Synchron Syustems Dat Drug Free Urine ControlDIF · Traditional | 05/21/1997SE |
| K935362 | P-Amylase ControlJJX · Traditional | 01/27/1994SE |
| K904219 | Synchron CX 7 Clinical AnalyzerJJE · Traditional | 10/22/1990SE |
| K904220 | Synchron CX4-CEJJE · Traditional | 10/15/1990SE |
| K893583 | Beckman Cholinesterase Reagent KitDIH · Traditional | 08/15/1989SE |
Questions and answers
When was Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206 cleared by the FDA?
Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206 (K991707) received a 510(k) decision of Substantially Equivalent on June 1, 1999, 13 days after the submission was received.
What is the product code of K991707?
The FDA product code is DHX – System, Test, Carcinoembryonic Antigen, a Class II (moderate risk) device regulated under 21 CFR 866.6010.