Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K052914
Device Classification Name
Electrode, Ion Specific, Potassium
More FDA Info for this Device
510(K) Number
K052914
Device Name
Electrode, Ion Specific, Potassium
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY GB
Other 510(k) Applications for this Company
Contact
PAULINE ARMSTRONG
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
10/14/2005
Decision Date
03/31/2006
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