# K852969: Rotaclone Rotavirus Diagnostic Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Bioscience Corp.
- Decided: Nov 5, 1985 after 113 days
- Product code: LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus)
- Device class: 1
- Regulation: 21 CFR 866.3405
- 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
- Dec 1, 2021 · Class II · Z-0552-2022: Product stored incorrectly in temperature controlled setting instead of refrigeration.

Source page: https://510kreport.com/device/K852969
Methodology: https://510kreport.com/methodology