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 K110394
Device Name ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
Applicant
Vital Diagnostics (Manufacturing) Ptyltd
189-199 Browns Rd.
Noble Park,  AU 3174
Applicant Contact MELITA LAMBIRIS
Correspondent
Vital Diagnostics (Manufacturing) Ptyltd
189-199 Browns Rd.
Noble Park,  AU 3174
Correspondent Contact MELITA LAMBIRIS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received02/11/2011
Decision Date 06/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-