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 Colorimetric, Xylose
510(k) Number K991156
Device Name GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
Applicant
Great Smokies Diagnostic Laboratory
63 Zillicoa St.
Asheville,  NC  28801
Applicant Contact STEPHEN BARRIE
Correspondent
Great Smokies Diagnostic Laboratory
63 Zillicoa St.
Asheville,  NC  28801
Correspondent Contact STEPHEN BARRIE
Regulation Number862.1820
Classification Product Code
JOC  
Date Received04/07/1999
Decision Date 05/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-