Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112550
Device Classification Name
Abnormal Hemoglobin Quantitation
More FDA Info for this Device
510(K) Number
K112550
Device Name
Abnormal Hemoglobin Quantitation
Applicant
SEBIA
400-1705 CORPORATE DRIVE
NORCROSS, GA 30096 US
Other 510(k) Applications for this Company
Contact
KAREN ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
864.7415
More FDA Info for this Regulation Number
Classification Product Code
GKA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/01/2011
Decision Date
05/25/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact