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 Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K853696
Device Name RUBELLA IGG EIA TEST KIT
Applicant
Labsystems, Inc.
P.O. Box 48723
Chicago,  IL  60648
Applicant Contact NANCY SKOWRONSKI
Correspondent
Labsystems, Inc.
P.O. Box 48723
Chicago,  IL  60648
Correspondent Contact NANCY SKOWRONSKI
Regulation Number866.3510
Classification Product Code
LFX  
Date Received09/05/1985
Decision Date 06/17/1986
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
-
-