Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K193397
Device Classification Name
Enzyme Immunoassay, Digoxin
More FDA Info for this Device
510(K) Number
K193397
Device Name
Enzyme Immunoassay, Digoxin
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown, NY 10591 US
Other 510(k) Applications for this Company
Contact
Anoop Joy
Other 510(k) Applications for this Contact
Regulation Number
862.3320
More FDA Info for this Regulation Number
Classification Product Code
KXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/06/2019
Decision Date
07/16/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact