Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K092849
Device Classification Name
Electrode, Ion Specific, Potassium
More FDA Info for this Device
510(K) Number
K092849
Device Name
Electrode, Ion Specific, Potassium
Applicant
EPOCAL, INC.
2060 WALKLEY RD.
OTTAWA, ONTARIO K1G-3P5 CA
Other 510(k) Applications for this Company
Contact
ROY LAYER
Other 510(k) Applications for this Contact
Regulation Number
862.1600
More FDA Info for this Regulation Number
Classification Product Code
CEM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/16/2009
Decision Date
03/30/2010
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