# K192110: Vitek Densichek

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 31, 2019 after 87 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050002 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083536: Densichek Plus, bioMerieux, Inc. (2009) Summary page 4.

## Indications for use
The VITEK DENSICHEK instrument is an accessory intended for use with the VITEK 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to the microorganism concentrations. VITEK DENSICHEK is intended for use with polystyrene tubes, and the reading range is 0.00 to 4.00 McFarland. The VITEK DENSICHEK has applications as an in vitro diagnostic medical device, or in an industry setting.

Source page: https://510kreport.com/device/K192110
Methodology: https://510kreport.com/methodology