Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K112742
Device Name AUDIT MICROLQ SPINAL FLUID CONTROL
Applicant
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD,  CA  92008
Applicant Contact DESSI LYAKOV
Correspondent
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD,  CA  92008
Correspondent Contact DESSI LYAKOV
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/21/2011
Decision Date 06/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-