ACS:180 & Advia Centaur Afp Immunoassay
FDA 510(k) K020806 · Bayer Corp.
510(k) numberK020806
Submission
- Device name
- ACS:180 & Advia Centaur Afp Immunoassay
- Applicant
- Bayer Corp.
Medfield, MA, US - Received
- March 12, 2002
- Decision date
- March 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code LOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220176 | Elecsys AFPLOJ · Traditional | Roche Diagnostics | 09/15/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | Ortho Clinical Diagnostics | 06/15/2022SE |
| K090236 | Dimension Vista Afp Flex Reagent Cartridge, Model 6454LOJ · Traditional | Siemens Healthcare Diagnostics | 04/27/2009SE |
| K081709 | Olympus Afp - Alpha-FetoproteinLOJ · Traditional | Olympus Life Science Research Europa GmbH (Europa) | 03/16/2009SE |
| K080017 | Vidas Afp AssayLOJ · Traditional | bioMerieux, Inc. | 09/26/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | Dade Behring, Inc. | 06/04/2008SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | Tosoh Medics, Inc. | 12/17/2002SE |
| K020807 | Afp Assay for the Advia Integrated Modular SystemLOJ · Traditional | Bayer Diagnostics Corp. | 10/01/2002SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | Diagnostic Systems Laboratories, Inc. | 06/21/1999SE |
| K983031 | Vitros Immunodiagnostic Products Afp AssayLOJ · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/18/1998SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K024062 | Ascensia Breeze Blood Glucose MeterCGA · Traditional | 03/03/2003SE |
| K023944 | Bayer Diagnostics Clinitest Pregnancy TestJHI · Abbreviated | 02/11/2003SE |
| K024017 | Bayer Advia Centaur HER-2/NEU AssayNCW · Traditional | 01/30/2003SE |
| K024234 | Ascensia Glucofacts; Ascensia Glucofacts ProfessionalNBW · Traditional | 01/23/2003SE |
| K022288 | Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional | 12/17/2002SE |
| K023584 | Ascensia Dex 2 Diabetes Care SystemNBW · Special | 11/20/2002SE |
| K020828 | Ca 125 Assay for the Advia Centaur SystemLTK · Traditional | 07/24/2002SE |
| K021428 | Clinitek Atlas Pro 12 Reagent Pak SystemJFY · Traditional | 07/05/2002SE |
| K013568 | Cea Assay for the Advia Integrated Modular SystemDHX · Traditional | 12/21/2001SE |
| K012337 | Bayer Advia Ims System; C-Reactive Protein SystemDCN · Traditional | 12/06/2001SE |
Questions and answers
When was ACS:180 & Advia Centaur Afp Immunoassay cleared by the FDA?
ACS:180 & Advia Centaur Afp Immunoassay (K020806) received a 510(k) decision of Substantially Equivalent on March 27, 2002, 15 days after the submission was received.
What is the product code of K020806?
The FDA product code is LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.