Product code DKX— Clinical Toxicology
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
- Classification name
- Thin Layer Chromatography, Barbiturate
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DKX
FDA has cleared devices under product code DKX between 1980 and 2003, filed by 2 applicant companies. 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
- 2003
- 1980
Top applicants under product code DKX
Recent clearances under product code DKX
Data sourced from openFDA. This site is unofficial and independent of the FDA.