Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130100
Device Classification Name
Solution-Test Standard-Conductivity, Dialysis
More FDA Info for this Device
510(K) Number
K130100
Device Name
Solution-Test Standard-Conductivity, Dialysis
Applicant
MESA LABORATORIES, INC.
12100 W 6th Ave
LAKEWOOD, CO 80228 US
Other 510(k) Applications for this Company
Contact
JAMIE LOUIE
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
FKH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/15/2013
Decision Date
04/18/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact