Product code GWD— Microbiology

HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER

Classification name
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Device class
Class 2
Regulation
21 CFR 866.3220
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GWD

FDA has cleared 2 devices under product code GWD between 1985 and 1987, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code GWD

Recent clearances under product code GWD

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