510(k) Premarket Notification

• Device Classification Name: Electrode, Ion Based, Enzymatic, Creatinine
• 510(k) Number: K973292
• Device Name: I-STAT SYSTEM
• Applicant: I-STAT CORP.; 303 COLLEGE RD. EAST; PRINCETON, NJ 08540
• Applicant Contact: IMANTS R LAUKS
• Correspondent: I-STAT CORP.; 303 COLLEGE RD. EAST; PRINCETON, NJ 08540
• Correspondent Contact: IMANTS R LAUKS
• Regulation Number: 862.1225
• Classification Product Code: CGL
• Date Received: 09/02/1997
• Decision Date: 10/20/1997
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Statement: Statement
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls