SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR

System, Test, C-reactive Protein

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems C-reactive Protein (c-rp) Reagent; Synchron Systems Cx C-rp Calibrator.

Pre-market Notification Details

• Device ID: K021572
• 510k Number: K021572
• Device Name: SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
• Classification: System, Test, C-reactive Protein
• Applicant: BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822
• Contact: Mary Beth Tang
• Correspondent: Mary Beth Tang; BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822
• Product Code: DCN
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-14
• Decision Date: 2002-07-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590224455	K021572	000