AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS

Flow Cytometric Reagents And Accessories.

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Aquios Cl Flow Cytometer, Aquios Tetra-1 Panel,aquios Tetra-2+panel, Aquios Immuno-trol, Aquios Immuno-trol Low, Aquios.

Pre-market Notification Details

• Device ID: K141932
• 510k Number: K141932
• Device Name: AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
• Classification: Flow Cytometric Reagents And Accessories.
• Applicant: BECKMAN COULTER, INC. 11800 SW 147TH AVE Miami, FL 33196
• Contact: Anthony Dennis
• Correspondent: Anthony Dennis; BECKMAN COULTER, INC. 11800 SW 147TH AVE Miami, FL 33196
• Product Code: OYE
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-16
• Decision Date: 2015-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590225889	K141932	000
15099590225865	K141932	000
15099590225841	K141932	000
15099590225827	K141932	000
15099590225803	K141932	000
15099590225773	K141932	000
15099590225759	K141932	000
15099590225735	K141932	000
15099590225704	K141932	000