Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K110968 |
Device Name |
PROFLU+ ASSAY |
Applicant |
GEN-PROBE PRODESSE, INC |
W229 N1870 WESTWOOD DR |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
KAREN HARRINGTON |
Correspondent |
GEN-PROBE PRODESSE, INC |
W229 N1870 WESTWOOD DR |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
KAREN HARRINGTON |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/06/2011 |
Decision Date | 06/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|