Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K954318
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rubella
More FDA Info for this Device
510(K) Number
K954318
Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD. D49C
ABBOTT PARK, IL 60064-3500 US
Other 510(k) Applications for this Company
Contact
MARY SPIEWAK
Other 510(k) Applications for this Contact
Regulation Number
866.3510
More FDA Info for this Regulation Number
Classification Product Code
LFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/1995
Decision Date
05/14/1996
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