Product code JHF— Clinical Chemistry
PG-NUMERIC(TM)
- Classification name
- Colorimetric Method, Lecithin/Sphingomyelin Ratio
- Device class
- Class 2
- Regulation
- 21 CFR 862.1455
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code JHF
FDA has cleared devices under product code JHF between 1989 and 1995, 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
- 1995
- 1989
Top applicants under product code JHF
Recent clearances under product code JHF
Data sourced from openFDA. This site is unofficial and independent of the FDA.