NO-BOIL SOLID PHASE SIMUL TRAC B12

Radioassay, Vitamin B12

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 No-boil Solid Phase Simul Trac B12.

Pre-market Notification Details

• Device ID: K822721
• 510k Number: K822721
• Device Name: NO-BOIL SOLID PHASE SIMUL TRAC B12
• Classification: Radioassay, Vitamin B12
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: CDD
• CFR Regulation Number: 862.1810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-09-07
• Decision Date: 1983-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817830022535	K822721	000