Access Folate Assay
by Beckman Coulter, Inc. 2 variants
510(k) K223590
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223590 | Date23 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K223590
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CGN
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1295
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Access Folate Assay is a paramagnetic particle, chemiluminescent immunoassay designed for the quantitative measurement of folic acid levels. It is classified as a Clinical Chemistry device and is used to determine folate concentrations in human serum, lithium heparin plasma, and red blood cells.
This assay is intended for use with the Access Immunoassay Systems and is supplied as a reagent kit. It has received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent Substantial Equivalence). The device is regulated under the classification of Class II (device class=2) and falls under the regulation number 862.1295.