510(k) Premarket Notification

• Device Classification Name: glucose oxidase, glucose
• 510(k) Number: K001387
• Device Name: I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
• Applicant: I-STAT CORP.; 104 WINDSOR CENTER DR.; EAST WINDSOR, NJ 08520
• Applicant Contact: PAUL VANDERWERF
• Correspondent: I-STAT CORP.; 104 WINDSOR CENTER DR.; EAST WINDSOR, NJ 08520
• Correspondent Contact: PAUL VANDERWERF
• Regulation Number: 862.1345
• Classification Product Code: CGA
• Date Received: 05/02/2000
• Decision Date: 10/05/2000
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls