SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT

Igg, Antigen, Antiserum, Control

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Lx Systems Immunoglobulin G/a/m Reagent.

Pre-market Notification Details

• Device ID: K965108
• 510k Number: K965108
• Device Name: SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
• Classification: Igg, Antigen, Antiserum, Control
• Applicant: BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000
• Contact: Kathleen M Jaker
• Correspondent: Kathleen M Jaker; BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000
• Product Code: DEW
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-20
• Decision Date: 1997-03-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590233372	K965108	000
15099590231620	K965108	000
15099590231613	K965108	000