Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K131284
Device Classification Name
System,Test,Biotinidase
More FDA Info for this Device
510(K) Number
K131284
Device Name
System,Test,Biotinidase
Applicant
WALLAC OY
940 WINTER STREET
WALTHAM, MA 02451 US
Other 510(k) Applications for this Company
Contact
JEANETTE SCHIER-PUGSLEY
Other 510(k) Applications for this Contact
Regulation Number
862.1118
More FDA Info for this Regulation Number
Classification Product Code
NAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2013
Decision Date
11/14/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact