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 K935547
Device Name CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
Applicant
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact BRIAN J YOUNG
Correspondent
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact BRIAN J YOUNG
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/17/1993
Decision Date 01/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-