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 System, Test, Low Density, Lipoprotein
510(k) Number K964064
Device Name RDI LIPIDIRECT MAGNETIC LDL REAGENT
Applicant
Reference Diagnostics, Inc.
23 Crosby Dr.
Bedford,  MA  01730
Applicant Contact JOSEPH LAWLOR, PH.D.
Correspondent
Rdd Consultants, Inc.
401 Spruce St.
Louisville,  CO  80027
Correspondent Contact NANCY SAUER
Regulation Number862.1475
Classification Product Code
MRR  
Date Received10/10/1996
Decision Date 11/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-