# K973213: Fresh Cells LLC-MK2

- 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
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. Our reading found no predicate number; beside “510(k)” the summary reads “K936271”, which our checks could not confirm as its predicate.
- (no number) BioWhittaker cell cultures: named in the summary without a submission number

## Indications for use
FreshCellas™ 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/K973213
Methodology: https://510kreport.com/methodology