510(k) Premarket Notification

• Device Classification Name: electrolyte controls (assayed and unassayed)
• 510(k) Number: K934641
• Device Name: I-STAT CONTROL LEVELS 1,2,3
• Applicant: I-STAT CORP.; 303 COLLEGE RD. EAST; PRINCETON, NJ 08540
• Applicant Contact: ROBERT F MARTIN
• Correspondent: I-STAT CORP.; 303 COLLEGE RD. EAST; PRINCETON, NJ 08540
• Correspondent Contact: ROBERT F MARTIN
• Regulation Number: 862.1660
• Classification Product Code: JJR
• Subsequent Product Code: JFP
• Date Received: 09/21/1993
• Decision Date: 12/09/1993
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No