510(k) Premarket Notification Database
Device Classification Name |
acid, vanilmandelic, diazo, p-nitroaniline/vanillin
|
510(k) Number | K953077 |
Device Name | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM |
Applicant |
BECKMAN INSTRUMENTS, INC.
|
200 south kraemer blvd. |
w-337 |
brea,
CA
92821 620 |
|
Contact | sheri l hall |
Regulation Number | 862.1795 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/30/1995 |
Decision Date | 01/05/1996 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Statement/Summary/Purged Status |
Summary only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|