Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K222829
Device Classification Name
Antigens, All Types, Escherichia Coli
More FDA Info for this Device
510(K) Number
K222829
Device Name
Antigens, All Types, Escherichia Coli
Applicant
Meridian Bioscience Inc.
3471 River Hills Drive
Cincinnati, OH 45244 US
Other 510(k) Applications for this Company
Contact
Heather Planck
Other 510(k) Applications for this Contact
Regulation Number
866.3255
More FDA Info for this Regulation Number
Classification Product Code
GMZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2022
Decision Date
04/17/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact