ANALYST THYROXINE (T4) ROTOR

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

THE DU PONT CO.

The following data is part of a premarket notification filed by The Du Pont Co. with the FDA for Analyst Thyroxine (t4) Rotor.

Pre-market Notification Details

• Device ID: K884700
• 510k Number: K884700
• Device Name: ANALYST THYROXINE (T4) ROTOR
• Classification: Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
• Applicant: THE DU PONT CO. CHESTNUT RUN PLAZA P.O. BOX 80715 Wilmington, DE
• Contact: Richard M Vaught
• Correspondent: Richard M Vaught; THE DU PONT CO. CHESTNUT RUN PLAZA P.O. BOX 80715 Wilmington, DE
• Product Code: KLI
• CFR Regulation Number: 862.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-11-09
• Decision Date: 1989-01-27