Product code DEF— Immunology

LPIA-FERRITIN ASSAY

Classification name: Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
Device class: Class 1
Regulation: 21 CFR 866.5425
Advisory panel: Immunology
Total cleared: 1
First cleared: 1992-12-23
Most recent: 1992-12-23

Market context for product code DEF

FDA has cleared 1 device under product code DEF, all in 1992, filed by 1 applicant company. 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.

Top applicants under product code DEF

Seradyn, Inc.1 clearance

Recent clearances under product code DEF

K924186 — LPIA-FERRITIN ASSAYSeradyn, Inc.·1992-12-23

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