Product code DMY— Clinical Toxicology
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
- Classification name
- Gas Chromatography, Morphine
- Device class
- Class 2
- Regulation
- 21 CFR 862.3640
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DMY
FDA has cleared device under product code DMY, all in 1999, 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.
Top applicants under product code DMY
Recent clearances under product code DMY
Data sourced from openFDA. This site is unofficial and independent of the FDA.