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 Epstein-Barr Virus, Other
510(k) Number K921628
Device Name EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
Applicant
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact MARY FRICK
Correspondent
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact MARY FRICK
Regulation Number866.3235
Classification Product Code
LSE  
Date Received04/06/1992
Decision Date 09/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-