510(k) clearances

Xpert® FII & FV

Cepheid · Hematology

K250218Substantially EquivalentSpecialNPR
Open FDA's page for this record
Third party flag
N
City
Sunnyvale
Advisory committee description
Hematology
Address 1
904 Caribbean Dr.
Statement or summary
Summary
Product code
NPR
Zip code
94089
Applicant
Cepheid
Decision date
2025-02-21
Decision code
SESE
Country code
US
Device name
Xpert® FII & FV
Advisory committee
HE
Contact
Suzette Chance
K number
K250218
State
CA
Date received
2025-01-24
Review advisory committee
HE
Postal code
94089
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Medical specialty description
Hematology
Regulation number
864.7280
Device class
2
Registration number
3016838963, 3004530258, 3005406097, 2243471
FEI number
3016838963, 3004530258, 3005406097, 2243471
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.