SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

Alkaline Picrate, Colorimetry, Creatinine

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Lx20 Clinical Systems, Creatinine Test Systems.

Pre-market Notification Details

• Device ID: K071277
• 510k Number: K071277
• Device Name: SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
• Classification: Alkaline Picrate, Colorimetry, Creatinine
• Applicant: BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000
• Contact: Tara M Viviani
• Correspondent: Tara M Viviani; BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000
• Product Code: CGX
• CFR Regulation Number: 862.1225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-07
• Decision Date: 2007-06-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590233525	K071277	000
15099590233426	K071277	000
15099590233419	K071277	000
15099590233402	K071277	000