Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K030045
Device Classification Name
Colorimetry, Cholinesterase
More FDA Info for this Device
510(K) Number
K030045
Device Name
Colorimetry, Cholinesterase
Applicant
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING, TX 75063-3104 US
Other 510(k) Applications for this Company
Contact
MICHAEL CAMPBELL
Other 510(k) Applications for this Contact
Regulation Number
862.3240
More FDA Info for this Regulation Number
Classification Product Code
DIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2003
Decision Date
02/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
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