Product code GPO— Microbiology

NEOTHROMITIN(R)

Classification name: Antigen, Cf, Typhus Fever Group
Device class: Class 1
Regulation: 21 CFR 866.3500
Advisory panel: Microbiology
Total cleared: 1
First cleared: 1992-12-01
Most recent: 1992-12-01

Market context for product code GPO

FDA has cleared 1 device under product code GPO, 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 GPO

Behring Diagnostics, Inc.1 clearance

Recent clearances under product code GPO

K924395 — NEOTHROMITIN(R)Behring Diagnostics, Inc.·1992-12-01

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