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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K843986
Device Name STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3
Applicant
UNITED DIAGNOSTICS, INC.
8 TECH CIRCLE
NATICK,  MA  01760
Applicant Contact NORMAN KLEINMAN
Correspondent
UNITED DIAGNOSTICS, INC.
8 TECH CIRCLE
NATICK,  MA  01760
Correspondent Contact NORMAN KLEINMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/11/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-