CORTI-COTE CORTISOL SOLID PHASE RADIO

Radioimmunoassay, Cortisol

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 Corti-cote Cortisol Solid Phase Radio.

Pre-market Notification Details

• Device ID: K842365
• 510k Number: K842365
• Device Name: CORTI-COTE CORTISOL SOLID PHASE RADIO
• Classification: Radioimmunoassay, Cortisol
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: CGR
• CFR Regulation Number: 862.1205 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-06-15
• Decision Date: 1984-08-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817830022627	K842365	000
00817830022610	K842365	000
00817830022313	K842365	000