Product code JHN— Clinical Chemistry
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
- Classification name
- Turbidimetric Method, Lipoproteins
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code JHN
FDA has cleared devices under product code JHN between 1994 and 1995, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1995
- 1994
Top applicants under product code JHN
Recent clearances under product code JHN
- K950382 — APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
- K950383 — APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
- K952615 — WAKO AUTOKIT APO A1
- K952425 — OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
- K952466 — OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
- K932603 — APOLIPOPROTIEN B (APO B)
- K932606 — APOLIPOPROTIEN A-1 (APO A-1)
Data sourced from openFDA. This site is unofficial and independent of the FDA.