Product code KWX— Clinical Chemistry
UBAS
- Classification name
- Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
- Device class
- Class 2
- Regulation
- 21 CFR 862.1187
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code KWX
FDA has cleared devices under product code KWX between 1998 and 2000, 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
- 2000
- 1998
Top applicants under product code KWX
Recent clearances under product code KWX
Data sourced from openFDA. This site is unofficial and independent of the FDA.