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 extractable antinuclear antibody, antigen and control
510(k) Number K141328
Device Name QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE ROAD
SAN DIEGO,  CA  92131 -1638
Applicant Contact GABRIELLA LAKOS
Correspondent
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE ROAD
SAN DIEGO,  CA  92131 -1638
Correspondent Contact GABRIELLA LAKOS
Regulation Number866.5100
Classification Product Code
LLL  
Subsequent Product Codes
JIT   JJX  
Date Received05/21/2014
Decision Date 02/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-