Automated Differential Cell Counter

Counter, Differential Cell

Becton Dickinson Immunocytometry Systems

The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Automated Differential Cell Counter.

Pre-market Notification Details

• Device ID: BK970046
• 510k Number: BK970046
• Device Name: Automated Differential Cell Counter
• Classification: Counter, Differential Cell
• Applicant: Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, CA 95131
• 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: 1997-12-22
• Decision Date: 1998-08-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382903405237	BK970046	000