Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K946068
Device Classification Name
System, Test, Beta-2-Microglobulin Immunological
More FDA Info for this Device
510(K) Number
K946068
Device Name
System, Test, Beta-2-Microglobulin Immunological
Applicant
THE BINDING SITE, LTD.
EAST TOWER, SUITE 600
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA, CA 90404 US
Other 510(k) Applications for this Company
Contact
JAY H GELLETR
Other 510(k) Applications for this Contact
Regulation Number
866.5630
More FDA Info for this Regulation Number
Classification Product Code
JZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/1994
Decision Date
01/30/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact