Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K203612
Device Classification Name
Antigen, Iha, Cytomegalovirus
More FDA Info for this Device
510(K) Number
K203612
Device Name
Antigen, Iha, Cytomegalovirus
Applicant
Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071 US
Other 510(k) Applications for this Company
Contact
Steven Appel
Other 510(k) Applications for this Contact
Regulation Number
866.3175
More FDA Info for this Regulation Number
Classification Product Code
LJO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2020
Decision Date
03/22/2021
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