Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K121759
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K121759
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
CONE BIOPRODUCTS
1012 N Austin St
SEGUIN, TX 78155 US
Other 510(k) Applications for this Company
Contact
WILL CONE
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2012
Decision Date
07/24/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact