DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR

Enzymatic Method, Bilirubin

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Dri-stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator.

Pre-market Notification Details

• Device ID: K053090
• 510k Number: K053090
• Device Name: DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
• Classification: Enzymatic Method, Bilirubin
• Applicant: BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822
• Contact: Eri Hirumi
• Correspondent: Eri Hirumi; BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822
• Product Code: JFM
• CFR Regulation Number: 862.1110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-02
• Decision Date: 2005-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590222642	K053090	000