Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151559
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
More FDA Info for this Device
510(K) Number
K151559
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO, NY 14228 US
Other 510(k) Applications for this Company
Contact
KEVIN LAWSON
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
06/10/2015
Decision Date
03/11/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact