BD FACSCanto II Flow Cytometer (4-2-2 And 5-3 Configurations), BD FACSCanto Flow Cytometer (4-3-3 Configuration)

Flow Cytometric Reagents And Accessories.

BD Biosciences

The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Facscanto Ii Flow Cytometer (4-2-2 And 5-3 Configurations), Bd Facscanto Flow Cytometer (4-3-3 Configuration).

Pre-market Notification Details

• Device ID: K141468
• 510k Number: K141468
• Device Name: BD FACSCanto II Flow Cytometer (4-2-2 And 5-3 Configurations), BD FACSCanto Flow Cytometer (4-3-3 Configuration)
• Classification: Flow Cytometric Reagents And Accessories.
• Applicant: BD Biosciences 2350 Qume Dr. San Jose, CA 95131
• Contact: Terrance Thiel
• Correspondent: Terrance Thiel; BD Biosciences 2350 Qume Dr. San Jose, CA 95131
• Product Code: OYE
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-03
• Decision Date: 2015-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382906595287	K141468	000
00382906595232	K141468	000
00382906579256	K141468	000
00382906577740	K141468	000
00382906573384	K141468	000
00382903389629	K141468	000
00382906654212	K141468	000