# K093224: Densicheck Plus

- Pathway: 510(k) (Special)
- Applicant: bioMerieux, Inc.
- Decided: Nov 9, 2009 after 26 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 1.

## Indications for use
The DensiCHEK Tm Plus instrument is intended for use with the VITEK® and VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to microorganism concentrations. DensiCHEK Plus is indicated for use with polystyrene and glass test tubes and the reading range is 0.0 - 4.0 McFarland. The DensiChek m Plus has applications as an in vitro diagnostic device.

Source page: https://510kreport.com/device/K093224
Methodology: https://510kreport.com/methodology