FREE T3 SOLID PHASE RADIOIMMUNOASSAY

Radioimmunoassay, Total Triiodothyronine

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 Free T3 Solid Phase Radioimmunoassay.

Pre-market Notification Details

• Device ID: K840959
• 510k Number: K840959
• Device Name: FREE T3 SOLID PHASE RADIOIMMUNOASSAY
• Classification: Radioimmunoassay, Total Triiodothyronine
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: CDP
• CFR Regulation Number: 862.1710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-03-06
• Decision Date: 1984-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817830022511	K840959	000