# K905643: Bed Red D-Dimer Whole Blood Agglutination Assay

- Pathway: 510(k) (Traditional)
- Applicant: Agen Biomedical, Ltd.
- Decided: Apr 12, 1991 after 116 days
- Product code: GHH (Fibrin Split Products)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: 1 (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
- Jun 1, 2016 · Class II · Z-0314-2017: A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possib

Source page: https://510kreport.com/device/K905643
Methodology: https://510kreport.com/methodology