Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181438
Device Classification Name
Kappa, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K181438
Device Name
Kappa, Antigen, Antiserum, Control
Applicant
Diazyme Laboratories Inc.
12889 Gregg Court
Poway, CA 92130 US
Other 510(k) Applications for this Company
Contact
Abhijit Datta
Other 510(k) Applications for this Contact
Regulation Number
866.5550
More FDA Info for this Regulation Number
Classification Product Code
DFH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2018
Decision Date
06/26/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact