Device Classification Name |
test, vaginal, bacterial sialidase
|
510(k) Number |
K050755 |
Device Name |
MODIFICATION TO BVBLUE |
Applicant |
GRYPHUS DIAGNOSTICS, LLC |
16809 BRIARDALE ROAD |
ROCKVILLE,
MD
20855
|
|
Applicant Contact |
THOMAS M TSAKERIS |
Correspondent |
GRYPHUS DIAGNOSTICS, LLC |
16809 BRIARDALE ROAD |
ROCKVILLE,
MD
20855
|
|
Correspondent Contact |
THOMAS M TSAKERIS |
Regulation Number | 866.2660
|
Classification Product Code |
|
Date Received | 03/23/2005 |
Decision Date | 04/06/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|