# K962782: Freshfrozen Cells, Hep-2

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Aug 29, 1996 after 43 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, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus Parainfluenza HSV Poliovirus Coxsackie B RSV Measles

Source page: https://510kreport.com/device/K962782
Methodology: https://510kreport.com/methodology