Product code MLK— Clinical Toxicology
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
- Classification name
- Thin Layer Chromatography, Tricyclic Antidepressant Drugs
- Device class
- Class 2
- Regulation
- 21 CFR 862.3910
- Advisory panel
- Clinical Toxicology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MLK
FDA has cleared devices under product code MLK between 2001 and 2002, 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
- 2002
- 2001
Top applicants under product code MLK
Recent clearances under product code MLK
Data sourced from openFDA. This site is unofficial and independent of the FDA.