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 Calibrator, Multi-Analyte Mixture
510(k) Number K112029
Device Name ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
Applicant
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
JJY  
Date Received07/15/2011
Decision Date 08/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-