510(k) clearances

Elecsys HBsAg II quant II RxDx

Roche Diagnostics · Unknown

DEN260027UnknownDirectSJM
Open FDA's page for this record
Third party flag
N
City
Indianapolis
Advisory committee description
Unknown
Address 1
9115 Hague Rd.
Product code
SJM
Zip code
46250
Applicant
Roche Diagnostics
Decision date
2026-10-20
Decision code
DENG
Country code
US
Device name
Elecsys HBsAg II quant II RxDx
Contact
Lisa Klinedinst
K number
DEN260027
State
IL
Date received
2026-06-02
Review advisory committee
MI
Postal code
46250
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Registration number
9610126
FEI number
3002806559
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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.