MICROTAINER BRAND TUBE WITH EDTA(K2)

Tubes, Vials, Systems, Serum Separators, Blood Collection

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 Microtainer Brand Tube With Edta(k2).

Pre-market Notification Details

• Device ID: K940905
• 510k Number: K940905
• Device Name: MICROTAINER BRAND TUBE WITH EDTA(K2)
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: Russell J Arnsberger
• Correspondent: Russell J Arnsberger; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-02-24
• Decision Date: 1994-08-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382903659747	K940905	000
50382903659758	K940905	000