Product code CHW— Clinical Chemistry
CALCIUM GEN. 2
- Classification name
- Titrimetric With Edta And Indicator, Calcium
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code CHW
FDA has cleared devices under product code CHW between 1978 and 2020, filed by 3 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
- 2020
- 2012
- 1978
Top applicants under product code CHW
Recent clearances under product code CHW
Data sourced from openFDA. This site is unofficial and independent of the FDA.