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 Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K980312
Device Name NOVA LITE ENDOMYSIAL
Applicant
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131
Correspondent Contact BRYS C MYERS
Regulation Number866.5660
Classification Product Code
DBL  
Date Received01/27/1998
Decision Date 04/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-