# K843122: Resolve-CSF

- Pathway: 510(k) (Traditional)
- Applicant: Isolab, Inc.
- Decided: Nov 30, 1984 after 114 days
- Product code: DFI (Total Spinal-Fluid, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5860
- 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
- May 16, 2002 · Not classified · Z-0973-03: The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.

Source page: https://510kreport.com/device/K843122
Methodology: https://510kreport.com/methodology