510(k) clearances

Xpert C. difficile/Epi

Cepheid® · Microbiology

K243730Substantially EquivalentTraditionalOZN
Open FDA's page for this record
Third party flag
N
City
Sunnyvale
Advisory committee description
Microbiology
Address 1
904 Caribbean Dr.
Statement or summary
Summary
Product code
OZN
Zip code
94089
Applicant
Cepheid®
Decision date
2025-02-28
Decision code
SESE
Country code
US
Device name
Xpert C. difficile/Epi
Advisory committee
MI
Contact
Suzette Chance
K number
K243730
State
CA
Date received
2024-12-03
Review advisory committee
MI
Postal code
94089
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
C. Difficile Toxin Gene Amplification Assay
Medical specialty description
Microbiology
Regulation number
866.3130
Device class
2
Registration number
9610126, 2023365, 1524213, 1528450, 3004530258, 3006028115, 3007420875, 3003795116, 2243471, 3004013603, 1119779, 3016838963, 3012494290, 3012918440, 3004141078
FEI number
2023365, 1524213, 3004530258, 3006028115, 3002806559, 3007420875, 3003795116, 2243471, 3004013603, 1119779, 3016838963, 3012494290, 3012918440, 3004141078, 1000122536
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.