# K973212: Fresh Cells WI-38

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Sep 25, 1997 after 29 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
Longest line of descent: 1 generation back to K962306 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962306: Fresh Cells Multi-Well & Shell Vial Cultures, Diagnostic Hybrids, Inc. (1996). Our OCR of the scanned summary read “36271” beside “510(k)”; FDA’s K962306 is the only number that fits it and carries the summary’s name for the device. Summary page 1.

## Indications for use
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

Source page: https://510kreport.com/device/K973212
Methodology: https://510kreport.com/methodology