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 Electrophoretic Separation, Lipoproteins
510(k) Number K013466
Device Name SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
Applicant
HELENA LABORATORIES
P.O. BOX 752
1530 LINDBERGH DRIVE
BEAUMONT,  TX  77704
Applicant Contact PATRICIA FRANKS
Correspondent
HELENA LABORATORIES
P.O. BOX 752
1530 LINDBERGH DRIVE
BEAUMONT,  TX  77704
Correspondent Contact PATRICIA FRANKS
Regulation Number862.1475
Classification Product Code
JHO  
Date Received10/18/2001
Decision Date 12/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-