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FDA 510(k) Application Details - K221842
Device Classification Name
More FDA Info for this Device
510(K) Number
K221842
Device Name
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis, IN 46250 US
Other 510(k) Applications for this Company
Contact
Greg Mondics
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2022
Decision Date
12/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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