# K163436: Greiner Vacuette Urine Count and Culture, Mannitol tube

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Na, Inc.
- Decided: Mar 6, 2017 after 89 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- 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 K024240 (2003). 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)
- K024240: BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits, Bd (2003) Summary page 4.

## Indications for use
The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.

Source page: https://510kreport.com/device/K163436
Methodology: https://510kreport.com/methodology