Elecsys Folate III
FDA 510(k) K233060 · Roche Diagnostics
510(k) numberK233060
Submission
- Device name
- Elecsys Folate III
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- September 25, 2023
- Decision date
- June 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K223590 | Access Folate AssayCGN · Traditional | Beckman Coulter, Inc. | 08/23/2023SE |
| K192586 | LIAISON® FolateCGN · Traditional | DiaSorin, Inc. | 05/06/2020SE |
| K172201 | Atellica IM Folate AssayCGN · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/12/2018SE |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetCGN · Traditional | Diazyme Laboratories | 11/04/2016SE |
| K141426 | Elecsys Folate IIICGN · Traditional | Roche Diagnostics | 10/17/2014SE |
| K103716 | Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetCGN · Special | Roche Diagnostics | 05/12/2011SE |
| K092740 | Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls…CGN · Traditional | Abbott Laboratories | 03/05/2010SE |
| K091332 | Aia-Pack RBC FolateCGN · Traditional | Tosoh Bioscience, Inc. | 10/02/2009SE |
| K082340 | Roche Elecsys Folate III, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…CGN · Traditional | Roche Diagnostics Corp. | 06/19/2009SE |
| K060774 | Folate on the Access Immunoassay Systems, Model A14208CGN · Special | Beckman Coulter, Inc. | 04/21/2006SE |
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| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
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Questions and answers
When was Elecsys Folate III cleared by the FDA?
Elecsys Folate III (K233060) received a 510(k) decision of Substantially Equivalent on June 17, 2024, 266 days after the submission was received.
What is the product code of K233060?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.