# K091024: Chromid Mrsa Agar, Model: Ref 43 841

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 17, 2009 after 98 days
- Product code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)
- Device class: 2
- Regulation: 21 CFR 866.1700
- 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) BBL CHROMagar MRSA: named in the summary without a submission number

## Indications for use
chromlDTM MRSA agar is a selective and differential chromogenic medium for the qualitative detection of nasal colonization by methicillin-resistant S. aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. chromlDTM MRSA agar is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.

Source page: https://510kreport.com/device/K091024
Methodology: https://510kreport.com/methodology