Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071340
Device Classification Name
Enzymatic, Carbon-Dioxide
More FDA Info for this Device
510(K) Number
K071340
Device Name
Enzymatic, Carbon-Dioxide
Applicant
THERMO FISHER SCIENTIFIC OY
2 RATASTIE
VANTAA 01620 FI
Other 510(k) Applications for this Company
Contact
PAIVI SORMUNEN
Other 510(k) Applications for this Contact
Regulation Number
862.1160
More FDA Info for this Regulation Number
Classification Product Code
KHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2007
Decision Date
10/05/2007
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