Product code CKF— Clinical Chemistry
HICHEM ALP/AMP REAGENT KIT
- Classification name
- Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code CKF
FDA has cleared devices under product code CKF between 1996 and 2008, 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
- 2008
- 1996
Top applicants under product code CKF
Recent clearances under product code CKF
Data sourced from openFDA. This site is unofficial and independent of the FDA.