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FDA 510(k) Application Details - K203757
Device Classification Name
More FDA Info for this Device
510(K) Number
K203757
Device Name
Elecsys AMH
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250 US
Other 510(k) Applications for this Company
Contact
Edie Eads
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2020
Decision Date
06/10/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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