# K083536: Densichek Plus

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 11, 2009 after 287 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: 1 generation back to K050002 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050002: Vitek 2 Compact, bioMerieux, Inc. (2005) Summary page 1.
- (no number) VITEK 2 Compact: named in the summary without a submission number

## Most influential descendants
- K192110: Vitek Densichek (2019), 0 descendants of its own
- K093224: Densicheck Plus (2009), 0 descendants of its own

## Indications for use
The DensiCHEK m 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 Plus has applications as an in vitro diagnostic device.

Source page: https://510kreport.com/device/K083536
Methodology: https://510kreport.com/methodology