Product code GSI— Microbiology

SDL LISTERIA MONOCYTOGENES CONTROL

Classification name: Antigens, Slide And Tube, All Types, Listeria Monocytogenes
Device class: Class 1
Regulation: 21 CFR 866.3355
Advisory panel: Microbiology
Total cleared: 1
First cleared: 1984-03-23
Most recent: 1984-03-23

Market context for product code GSI

FDA has cleared 1 device under product code GSI, all in 1984, 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 GSI

Scientific Device Laboratory, Inc.1 clearance

Recent clearances under product code GSI

K840503 — SDL LISTERIA MONOCYTOGENES CONTROLScientific Device Laboratory, Inc.·1984-03-23

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