Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112545
Device Classification Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
More FDA Info for this Device
510(K) Number
K112545
Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE RD.
SAN DIEGO, CA 92131-1638 US
Other 510(k) Applications for this Company
Contact
MICHAEL MAHLER
Other 510(k) Applications for this Contact
Regulation Number
866.5660
More FDA Info for this Regulation Number
Classification Product Code
MOB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/01/2011
Decision Date
07/31/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact