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 electrode, ion specific, potassium
510(k) Number K112788
Device Name EASTLYTE NA/K/CA/PH
Applicant
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD,  MA  01730
Applicant Contact Photios Makris
Correspondent
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CHL   JFP   JGS  
Date Received09/26/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-