SOLID PHASE SIMUL TRAC VITAMIN B12

Acid, Folic, Radioimmunoassay

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 Solid Phase Simul Trac Vitamin B12.

Pre-market Notification Details

• Device ID: K822728
• 510k Number: K822728
• Device Name: SOLID PHASE SIMUL TRAC VITAMIN B12
• Classification: Acid, Folic, Radioimmunoassay
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: CGN
• CFR Regulation Number: 862.1295 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-09-08
• Decision Date: 1982-11-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817830022603	K822728	000
00817830022597	K822728	000
00817830022542	K822728	000