Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K970177
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K970177
Device Name
System, Test, Anticardiolipin Immunological
Applicant
IMMCO DIAGNOSTICS, INC.
963 KENMORE AVE.
BUFFALO, NY 14223 US
Other 510(k) Applications for this Company
Contact
RICHARD E GRECO, R.A.C.
Other 510(k) Applications for this Contact
Regulation Number
866.5660
More FDA Info for this Regulation Number
Classification Product Code
MID
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/17/1997
Decision Date
06/11/1997
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