LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR

Lymphocyte Separation Medium

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Leucoprep(r) Brand Cell Separat Tube W/sodium Citr.

Pre-market Notification Details

• Device ID: K911731
• 510k Number: K911731
• Device Name: LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
• Classification: Lymphocyte Separation Medium
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: J Arnsberger
• Correspondent: J Arnsberger; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: JCF
• CFR Regulation Number: 864.8500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-04-17
• Decision Date: 1992-12-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903627610	K911731	000
50382903627603	K911731	000