Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191360
Device Classification Name
Electrode, Ion Specific, Calcium
More FDA Info for this Device
510(K) Number
K191360
Device Name
Electrode, Ion Specific, Calcium
Applicant
Abbott Point of Care, Inc.
400 College Road East
Princeton, NJ 08540 US
Other 510(k) Applications for this Company
Contact
Susan Tibedo
Other 510(k) Applications for this Contact
Regulation Number
862.1145
More FDA Info for this Regulation Number
Classification Product Code
JFP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2019
Decision Date
02/14/2020
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