Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213858
Device Classification Name
Calprotectin, Fecal
More FDA Info for this Device
510(K) Number
K213858
Device Name
Calprotectin, Fecal
Applicant
DiaSorin Inc.
1951 Northwestern Ave
Stillwater, MN 55082 US
Other 510(k) Applications for this Company
Contact
Christa Blaisdell
Other 510(k) Applications for this Contact
Regulation Number
866.5180
More FDA Info for this Regulation Number
Classification Product Code
NXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2021
Decision Date
07/26/2022
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact