Culture Media, Antifungal, Susceptibility Test
Antifungal Susceptibility Test Culture Media are specialized laboratory media used to cultivate fungal organisms and assess their susceptibility to antifungal drugs, enabling clinical laboratories to guide appropriate antifungal therapy for patients with fungal infections. Classified as a Class 2 device under 21 CFR 866.1700 within the Microbiology specialty, they require 510(k) premarket notification. They carry no implant or life-sustaining flags.
Research product code MJE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MJE
- Device Class
- FDA class 2
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | Nov 26, 2007 | Substantially Equivalent | Remel, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.