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 Calibrator, Multi-Analyte Mixture
510(k) Number K033061
Device Name CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
Applicant
Diamond Diagnostics, Inc.
331 Fiske St.
Holliston,  MA  01746
Applicant Contact LINDA M STUNDTNER
Correspondent
Diamond Diagnostics, Inc.
331 Fiske St.
Holliston,  MA  01746
Correspondent Contact LINDA M STUNDTNER
Regulation Number862.1150
Classification Product Code
JIX  
Date Received09/29/2003
Decision Date 11/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-