THYROXINE ANALYSIS PRODUCTS/RADIO-FREE

Radioimmunoassay, Free Thyroxine

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 Thyroxine Analysis Products/radio-free.

Pre-market Notification Details

• Device ID: K823264
• 510k Number: K823264
• Device Name: THYROXINE ANALYSIS PRODUCTS/RADIO-FREE
• Classification: Radioimmunoassay, Free Thyroxine
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: CEC
• CFR Regulation Number: 862.1695 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-11-02
• Decision Date: 1983-01-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817830022504	K823264	000
00817830022498	K823264	000