# K962311: Freshfrozencells

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Aug 29, 1996 after 73 days
- Product code: KIR (Cells, Animal And Human, Cultured)
- Device class: 1
- Regulation: 21 CFR 864.2280
- 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) BioWhittaker cell cultures, Cryopreserved ampules: named in the summary without a submission number

## Indications for use
Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus Parainfluenza HSV Poliovirus Influenza RSV Measles Rotavirus Munmps

Source page: https://510kreport.com/device/K962311
Methodology: https://510kreport.com/methodology