Product code GNK— Microbiology

ECHO TYPE 11 CF ANTIGEN

Classification name: Antisera, Cf, Echovirus 1-34
Device class: Class 1
Regulation: 21 CFR 866.3205
Advisory panel: Microbiology
Total cleared: 3
First cleared: 1985-11-07
Most recent: 1985-11-07

Market context for product code GNK

FDA has cleared 3 devices under product code GNK, all in 1985, 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 GNK

Hillcrest Biologicals3 clearances

Recent clearances under product code GNK

K853156 — ECHO TYPE 16 CF ANTIGENHillcrest Biologicals·1985-11-07
K853157 — ECHO TYPE 11 CF ANTIGENHillcrest Biologicals·1985-11-07
K853165 — ECHO TYPE 30 CF ANTIGENHillcrest Biologicals·1985-11-07

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