Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K153644
Device Classification Name
Hexokinase, Glucose
More FDA Info for this Device
510(K) Number
K153644
Device Name
Hexokinase, Glucose
Applicant
ELITechGroup
ZONE INDUSTRIELLE
Sees 61500 FR
Other 510(k) Applications for this Company
Contact
Valerie Gourdon
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2015
Decision Date
09/07/2016
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