DeviceClearance

Product code GRL— Microbiology

SALMONELLA & SHIGELLA GROUPING SERA

Classification name
Antigens, All Groups, Salmonella Spp.
Device class
Class 2
Regulation
21 CFR 866.3550
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GRL

FDA has cleared 2 devices under product code GRL between 1982 and 1995, 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 GRL

Recent clearances under product code GRL

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