Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062180
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K062180
Device Name
Catalytic Methods, Amylase
Applicant
HORIBA ABX
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER, HERAULT 34184 FR
Other 510(k) Applications for this Company
Contact
TIM LAWTON
Other 510(k) Applications for this Contact
Regulation Number
862.1070
More FDA Info for this Regulation Number
Classification Product Code
JFJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2006
Decision Date
10/02/2006
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