# K971508: RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Whittaker, Inc., A Cambrex Co.
- Decided: Sep 17, 1997 after 145 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) Primary Rhesus Monkey Kidney Cell Culture: named in the summary without a submission number

## Indications for use
RHMK II is intended for use in the isolation and identification of virus in various clinical specimens from patients suspected of having a viral infection.

Source page: https://510kreport.com/device/K971508
Methodology: https://510kreport.com/methodology