# K943691: Imx Folate

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Mfg., Inc.
- Decided: Mar 23, 1995 after 237 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 16, 2003 · Not classified · Z-0371-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0369-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0372-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0368-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0370-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

Source page: https://510kreport.com/device/K943691
Methodology: https://510kreport.com/methodology