Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K962055
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
More FDA Info for this Device
510(K) Number
K962055
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
AMERICAN LABORATORY PRODUCTS CO., LTD.
7 COLCHESTER RD.
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
05/28/1996
Decision Date
11/15/1996
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