DeviceClearance

Product code MHI— Microbiology

CELLABS GIARDIA CEL I.F. TEST

Classification name
Giardia Spp.
Device class
Class 2
Regulation
21 CFR 866.3220
Advisory panel
Microbiology
Total cleared
27
First cleared
Most recent

Market context for product code MHI

FDA has cleared 27 devices under product code MHI between 1991 and 2013, filed by 13 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 MHI

Recent clearances under product code MHI

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