510(k) Premarket Notification

• Device Classification Name: electrode, ion specific, potassium
• 510(K) Number: K121040
• Model: 0-DD-SMARTLYTE
• Device Name: SMARTLYTE ELECTROLYTE ANALYZER
• Applicant: DIAMOND DIAGNOSTICS, INC.; 333 fiske st.; holliston, MA 01746
• Contact: kathy cruz
• Regulation Number: 862.1600
• Classification Product Code: CEM
• Subsequent Product Codes: CGZ JFP JGS JIH
• Date Received: 04/05/2012
• Decision Date: 08/30/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Clinical Chemistry
• Review Advisory Committee: Clinical Chemistry
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No