Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190784
Device Classification Name
Calprotectin, Fecal
More FDA Info for this Device
510(K) Number
K190784
Device Name
Calprotectin, Fecal
Applicant
BUHLMANN Laboratories AG
Baselstrasse 55
Schonenbuch 4124 CH
Other 510(k) Applications for this Company
Contact
Laura Zurbrugg
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
03/27/2019
Decision Date
06/25/2019
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