• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name nitrophenylphosphate, alkaline phosphatase or isoenzymes
510(k) Number K113269
Device Name ELITTECH CLINICAL SYSTEMS ALP IFCC SL
Original Applicant
ELITECHGROUP
21720 23rd dr se
suite 150
bothell,  WA  98021
Original Contact debra k hutson
Regulation Number862.1050
Classification Product Code
CJE  
Date Received11/04/2011
Decision Date 12/29/2011
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
-
-