Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

510(k) Premarket Notification

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 


New Search Back To Search Results
Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) NumberK082717
Device NameAUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
Applicant
AALTO SCIENTIFIC LTD.
1959 kellogg ave.
carlsbad,  CA  92008
Contactbrandon j perez
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/18/2008
Decision Date 10/30/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Immunology
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
-
-
-
-
-