510(k) Premarket Notification Database
Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number | K041073 |
Device Name | DOCUMENT SALICYLATE CAL VER |
Applicant |
MICROGENICS CORP.
|
46360 fremont blvd. |
fremont,
CA
94538 |
|
Contact | david casal |
Regulation Number | 862.1660 |
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 05/21/2004 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|