Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100060
Device Classification Name
Enzymatic, Carbon-Dioxide
More FDA Info for this Device
510(K) Number
K100060
Device Name
Enzymatic, Carbon-Dioxide
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
189-199 BROWNS RD
NOBLE PARK, VICTORIA 3174 AU
Other 510(k) Applications for this Company
Contact
MELITA LAMBIRIS
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
01/11/2010
Decision Date
12/15/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact