510(k) Premarket Notification Database
Device Classification Name |
eia, blastomyces dermatitidis
|
510(k) Number | K923859 |
Device Name | PREMIER BLASTOMYCES |
Applicant |
MERIDIAN DIAGNOSTICS, INC.
|
3471 river hills dr. |
cincinnati,
OH
45244 |
|
Contact | allen d nickol |
Regulation Number | 866.3060 |
Classification Product Code |
|
Date Received | 07/31/1992 |
Decision Date | 10/05/1992 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Statement/Summary/Purged Status |
Summary only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|