RPMI 1640 Agar w/MOPS and 2% Glucose
FDA 510(k)Class II (US FDA 510(k))
by Remel, Inc.
Identifiers
- 510(k) Number
- K072827 FDA 510(k)
- FDA Product Code
- MJE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1700 FDA 510(k)
- Regulation Number
- 866.1700 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
RPMI 1640 Agar w/MOPS and 2% Glucose is a culture medium used for antifungal susceptibility testing. It is a plated medium recommended for use with antibiotic gradient-based systems for the quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.
The device is supplied as a plated medium and is intended for use in microbiology laboratory settings. It is classified as a Class II medical device under regulation number 866.1700 with product code MJE, and received FDA 510(k) clearance (K072827) on November 26, 2007, as substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF RPMI 1640 AGAR w/ MOPS and 2% GLUCOSE - Thermo Fisher Scientific, RPMI 1640 Agar w/MOPS and 2% Glucose - Thermo Fisher Scientific, Thermo Scientific™ RPMI 1640 Agar w/MOPS and 2% Glucose
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072827 | Class II | Active |
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Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA 510(k) K072827 24 fields · synced Sep 21, 2026