510(k) Premarket Notification

• Device Classification Name: Acid, Lactic, Enzymatic Method
• 510(k) Number: K982071
• Device Name: I-STAT LACTATE TEST
• Applicant: I-Stat Corp.; 303 College Rd. E.; Princeton, NJ 08540
• Applicant Contact: PAUL VANDRWERF
• Correspondent: I-Stat Corp.; 303 College Rd. E.; Princeton, NJ 08540
• Correspondent Contact: PAUL VANDRWERF
• Regulation Number: 862.1450
• Classification Product Code: KHP
• Date Received: 06/12/1998
• Decision Date: 06/29/1998
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Summary: Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls