Product code JZW— Immunology

ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.

Classification name
Nephelometer
Device class
Class 1
Regulation
21 CFR 866.4540
Advisory panel
Immunology
Total cleared
11
First cleared
Most recent

Market context for product code JZW

FDA has cleared 11 devices under product code JZW between 1976 and 2000, filed by 8 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

Top applicants under product code JZW

Recent clearances under product code JZW

Data sourced from openFDA. This site is unofficial and independent of the FDA.