Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132200
Device Classification Name
Human Metapneumovirus (Hmpv) Rna Assay System
More FDA Info for this Device
510(K) Number
K132200
Device Name
Human Metapneumovirus (Hmpv) Rna Assay System
Applicant
GEN-PROBE PRODESSE, INC
20925 CROSSROADS CIRCLE
WAUKESHA, WI 53186 US
Other 510(k) Applications for this Company
Contact
EMILY ZIEGLER
Other 510(k) Applications for this Contact
Regulation Number
866.3980
More FDA Info for this Regulation Number
Classification Product Code
OEM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2013
Decision Date
08/14/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact