MHI · Class II · 21 CFR 866.3220

FDA Product Code MHI: Giardia Spp.

Leading manufacturers include Meridian Diagnostics, Inc. and Biosite Incorporated.

27
Total
27
Cleared
139d
Avg days
1991
Since

FDA 510(k) Cleared Giardia Spp. Devices (Product Code MHI)

27 devices
1–24 of 27
Cleared Nov 25, 1998
PREMIER GIARDIA
K982711
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Oct 06, 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
K982245
Biosite Incorporated
Microbiology · 102d
Cleared Jul 24, 1991
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408
Meridian Diagnostics, Inc.
Microbiology · 54d

About Product Code MHI - Regulatory Context