Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100829
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K100829
Device Name
Electrode, Ion Specific, Sodium
Applicant
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD, MA 01730 US
Other 510(k) Applications for this Company
Contact
Photios Makris
Other 510(k) Applications for this Contact
Regulation Number
862.1665
More FDA Info for this Regulation Number
Classification Product Code
JGS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/2010
Decision Date
01/14/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact