Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K091053
Device Classification Name
Parainfluenza Multiplex Nucleic Acid Assay
More FDA Info for this Device
510(K) Number
K091053
Device Name
Parainfluenza Multiplex Nucleic Acid Assay
Applicant
PRODESSE, INC.
W229 N1870 WESTWOOD DR.
WAUKESHA, WI 53186 US
Other 510(k) Applications for this Company
Contact
KAREN HARRINGTON
Other 510(k) Applications for this Contact
Regulation Number
866.3980
More FDA Info for this Regulation Number
Classification Product Code
OOU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2009
Decision Date
11/20/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact