Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143736
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K143736
Device Name
System, Test, Rheumatoid Factor
Applicant
IMMCO DIAGNOSTICS, INC.
9870 Hollingson Rd
Clarence, NY 14031 US
Other 510(k) Applications for this Company
Contact
Kevin Lawson
Other 510(k) Applications for this Contact
Regulation Number
866.5775
More FDA Info for this Regulation Number
Classification Product Code
DHR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2014
Decision Date
09/23/2015
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