Product code GSJ— Microbiology

MARLOW SUCTION/IRRIGATION PROBES

Classification name
Antiserum, Fluorescent, Francisella Tularensis
Device class
Class 2
Regulation
21 CFR 866.3280
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GSJ

FDA has cleared 1 device under product code GSJ, all in 1991, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code GSJ

Recent clearances under product code GSJ

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