Atlas FDA

GenePOC CDiff

FDA 510(k) clearance K172569 · decided 2017-11-22

Clearance details

K-number
K172569
Device name
GenePOC CDiff
Applicant
Genepoc, Inc.
Decision
Substantially Equivalent
Date received
2017-08-25
Decision date
2017-11-22
Days to decision
89 days
Clearance type
Traditional
Product code
OZN
Device class
2
Regulation number
866.3130
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Quebec, CA
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instru recall (Z-1019-2026)Meridian Bioscience Inc2026-01-05