FDA 510(k), K141932, AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
FDA 510(k), K141932, AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
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510(K) Number: K141932
Device Name: AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
Manufacturer: BECKMAN COULTER, INC.
Device Classification Name: Flow Cytometric Reagents And Accessories.
Regulation Number: 864.5220
Classification Product Code: OYE
Date Received: 07/16/2014
Decision Date: 04/10/2015
Regulation Medical Specialty: Hematology
Device Name: AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
Manufacturer: BECKMAN COULTER, INC.
Device Classification Name: Flow Cytometric Reagents And Accessories.
Regulation Number: 864.5220
Classification Product Code: OYE
Date Received: 07/16/2014
Decision Date: 04/10/2015
Regulation Medical Specialty: Hematology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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