BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER

Method, Nephelometric, Immunoglobulins (g, A, M)

BECKMAN COULTER, INC

The following data is part of a premarket notification filed by Beckman Coulter, Inc with the FDA for Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter.

Pre-market Notification Details

• Device ID: K130122
• 510k Number: K130122
• Device Name: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
• Classification: Method, Nephelometric, Immunoglobulins (g, A, M)
• Applicant: BECKMAN COULTER, INC 250 S. KRAEMER BLVD E1.SE. 01 Brea, CA 92821
• Contact: Amanda Brown
• Correspondent: Amanda Brown; BECKMAN COULTER, INC 250 S. KRAEMER BLVD E1.SE. 01 Brea, CA 92821
• Product Code: CFN
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-17
• Decision Date: 2014-01-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590227043	K130122	000
15099590221218	K130122	000