Aia-Pack Cea Calibration Verification Test Set
FDA 510(k) K924857 · Tosoh Medics, Inc.
510(k) numberK924857
Submission
- Device name
- Aia-Pack Cea Calibration Verification Test Set
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- September 28, 1992
- Decision date
- March 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | 12/18/2002SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | 12/17/2002SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K023891 | ST Aia-Pack Ca 125 Enzyme ImmunoassayLTK · Special | 12/06/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | 12/14/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | 08/16/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K990431 | Aia-Pack Ca 125LTK · Traditional | 06/03/1999SE |
Questions and answers
When was Aia-Pack Cea Calibration Verification Test Set cleared by the FDA?
Aia-Pack Cea Calibration Verification Test Set (K924857) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 171 days after the submission was received.
What is the product code of K924857?
The FDA product code is DHX – System, Test, Carcinoembryonic Antigen, a Class II (moderate risk) device regulated under 21 CFR 866.6010.