Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K002541
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K002541
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
REBECCA S AYASH
Other 510(k) Applications for this Contact
Regulation Number
864.7290
More FDA Info for this Regulation Number
Classification Product Code
GGP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2000
Decision Date
09/26/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact