Discs, Elution
Elution Discs (product code LTX) are microbiology laboratory devices used to elute or release compounds for antimicrobial susceptibility testing or related diagnostic procedures. Regulated under 21 CFR 866.1620 and classified as a Class 2 device, they require a 510(k) premarket notification and are eligible for third-party review. The device is reviewed under the Microbiology panel. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LTX
- Device Class
- FDA class 2
- Regulation Number
- 866.1620
- 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 2 510(k) clearances via K numbers.
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.