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 Latex Agglutination Assay, Rubella
510(k) Number K952544
Device Name COLORSLIDER RUBELLA
Applicant
Seradyn, Inc.
1200 Madison Ave.
Indianapolis,  IN  46225
Applicant Contact MARTIN J WEINSTEIN
Correspondent
Seradyn, Inc.
1200 Madison Ave.
Indianapolis,  IN  46225
Correspondent Contact MARTIN J WEINSTEIN
Regulation Number866.3510
Classification Product Code
LQN  
Date Received06/02/1995
Decision Date 01/17/1996
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
-
-