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 Solution-Test Standard-Conductivity, Dialysis
510(k) Number K033330
Device Name CONDUCTIVITY/TDS CALIBRATOR SOLUTION
Applicant
Mesa Laboratories, Inc.
12100 W. 6th Ave.
Lakewood,  CO  80228
Applicant Contact TODD ROMERO
Correspondent
Mesa Laboratories, Inc.
12100 W. 6th Ave.
Lakewood,  CO  80228
Correspondent Contact TODD ROMERO
Regulation Number876.5820
Classification Product Code
FKH  
Date Received10/16/2003
Decision Date 02/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-