SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

Calibrators, Drug Specific

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Op 300 Low And High Urine Calibrators.

Pre-market Notification Details

• Device ID: K993022
• 510k Number: K993022
• Device Name: SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
• Classification: Calibrators, Drug Specific
• Applicant: BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000
• Contact: Gail Lefebvre
• Correspondent: Gail Lefebvre; BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000
• Product Code: DLJ
• CFR Regulation Number: 862.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-09-09
• Decision Date: 1999-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590223304	K993022	000
15099590222017	K993022	000