# K072827: Rpmi 1640 Agar W/Mops and 2% Glucose

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Nov 26, 2007 after 54 days
- Product code: MJE (Culture Media, Antifungal, Susceptibility Test)
- 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) Mueller Hinton Agar w/ 2% NaCl: named in the summary without a submission number

## Indications for use
Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a plated medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.

Source page: https://510kreport.com/device/K072827
Methodology: https://510kreport.com/methodology