Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050574
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K050574
Device Name
Assay, Glycosylated Hemoglobin
Applicant
AXIS-SHIELD POC AS
P.O. BOX 262069
SAN DIEGO, CA 92196 US
Other 510(k) Applications for this Company
Contact
RONALD G LEONARDI
Other 510(k) Applications for this Contact
Regulation Number
864.7470
More FDA Info for this Regulation Number
Classification Product Code
LCP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/07/2005
Decision Date
07/22/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
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