Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130765
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K130765
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
ELITECHGROUP
21720 23RD DR SE
SUITE 150
BOTHELL, WA 98021 US
Other 510(k) Applications for this Company
Contact
DEBRA K HUTSON
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2013
Decision Date
04/04/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact