Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K983359
Device Classification Name
Iga, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K983359
Device Name
Iga, Antigen, Antiserum, Control
Applicant
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING, TX 75038 US
Other 510(k) Applications for this Company
Contact
LINDA MORRIS
Other 510(k) Applications for this Contact
Regulation Number
866.5510
More FDA Info for this Regulation Number
Classification Product Code
CZP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/1998
Decision Date
11/04/1998
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