# K962306: Fresh Cells Multi-Well & Shell Vial Cultures

- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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: named in the summary without a submission number

## Most influential descendants
- K973212: Fresh Cells WI-38 (1997), 0 descendants of its own

## 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 HSV Influenza Measles Mumps Parainfluenza Poliovirus RSV Rotavirus

Source page: https://510kreport.com/device/K962306
Methodology: https://510kreport.com/methodology