510(k) Premarket Notification Database
Device Classification Name |
igg (gamma chain specific), antigen, antiserum, control
|
510(k) Number | K940422 |
Device Name | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER |
Applicant |
THE BINDING SITE, LTD.
|
east tower, suite 600 |
2425 west olympic boulevard |
santa monica,
CA
90404 |
|
Contact | jay h geller |
Regulation Number | 866.5510 |
Classification Product Code |
|
Date Received | 01/19/1994 |
Decision Date | 05/27/1994 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Immunology
|
Statement/Summary/Purged Status |
Statement only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|