Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K954832
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
More FDA Info for this Device
510(K) Number
K954832
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
ORGENTEC
P.O. BOX 451
WINDHAM, NH 03087 US
Other 510(k) Applications for this Company
Contact
RICHARD CONLEY
Other 510(k) Applications for this Contact
Regulation Number
866.5100
More FDA Info for this Regulation Number
Classification Product Code
LJM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/1995
Decision Date
04/18/1996
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