Automated Differential Cell Counter

Counter, Differential Cell

BD Biosciences

The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Automated Differential Cell Counter.

Pre-market Notification Details

• Device ID: BK110037
• 510k Number: BK110037
• Device Name: Automated Differential Cell Counter
• Classification: Counter, Differential Cell
• Applicant: BD Biosciences 2350 Qume Drive San Jose, CA 95131 US
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-21
• Decision Date: 2011-10-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382903445639	BK110037	000