Product code LTX— Microbiology
ETEST FOR QUINUPRISTIN/DALFOPRISTIN
- Classification name
- Discs, Elution
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LTX
FDA has cleared devices under product code LTX between 1999 and 2000, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1999
Top applicants under product code LTX
Recent clearances under product code LTX
Data sourced from openFDA. This site is unofficial and independent of the FDA.