SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298

Enzymatic Method, Creatinine

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Enzymatic Creatinine (cr-e) Reagent, Model A60298.

Pre-market Notification Details

• Device ID: K093458
• 510k Number: K093458
• Device Name: SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
• Classification: Enzymatic Method, Creatinine
• Applicant: BECKMAN COULTER, INC. 200 S. KRAEMER BOULEVARD M/S W-110 Brea, CA 92822 -8000
• Contact: Marine Boyajian
• Correspondent: Marine Boyajian; BECKMAN COULTER, INC. 200 S. KRAEMER BOULEVARD M/S W-110 Brea, CA 92822 -8000
• Product Code: JFY
• CFR Regulation Number: 862.1225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-11-06
• Decision Date: 2009-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590625733	K093458	000