Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K041040
Device Classification Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
More FDA Info for this Device
510(K) Number
K041040
Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant
SWEDEN DIAGNOSTICS (GERMANY) GMBH
MUNZINGER STRASSE 7
FREIBURG D-79111 DE
Other 510(k) Applications for this Company
Contact
MICHAEL LINSS
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
04/22/2004
Decision Date
06/16/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact