# K960800: Cedia Red Blood Cell Folate (NO Boil Reagent Pack)

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 26, 1996 after 150 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) CEDIA® Red Blood Cell Folate Reagent Pack: named in the summary without a submission number

## Indications for use
The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be used in combination with the CEDIA® Folate (No Boil) Assay is a homogeneous enzyme binding assay for the quantitation of folate in red blood cells.

Source page: https://510kreport.com/device/K960800
Methodology: https://510kreport.com/methodology