Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K960669
Device Classification Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
More FDA Info for this Device
510(K) Number
K960669
Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant
MORAX
13805 WATERLOO RD.
CHELSEA, MI 48118 US
Other 510(k) Applications for this Company
Contact
BOREK JANIK
Other 510(k) Applications for this Contact
Regulation Number
866.5510
More FDA Info for this Regulation Number
Classification Product Code
CFF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/1996
Decision Date
07/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact