DeviceClearance

Product code GRM— Microbiology

BACTIGEN SALMONELLA-SHIGELLA TEST

Classification name
Antisera, All Groups, Salmonella Spp.
Device class
Class 2
Regulation
21 CFR 866.3550
Advisory panel
Microbiology
Total cleared
69
First cleared
Most recent

Market context for product code GRM

FDA has cleared 69 devices under product code GRM between 1982 and 1996, filed by 6 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 GRM

Recent clearances under product code GRM

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