Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K091846
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K091846
Device Name
Catalytic Methods, Amylase
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
Other 510(k) Applications for this Company
Contact
MARINE BOYAJIAN
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
06/22/2009
Decision Date
10/16/2009
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