Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K081030 |
Device Name |
MODIFICATION TO PROFLU+ ASSAY |
Applicant |
PRODESSE, INC. |
W229 N1870 WESTWOOD DR. |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
KAREN HARRINGTON |
Correspondent |
PRODESSE, INC. |
W229 N1870 WESTWOOD DR. |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
KAREN HARRINGTON |
Regulation Number | 866.3980
|
Classification Product Code |
|
Date Received | 04/11/2008 |
Decision Date | 05/02/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|