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