The following data is part of a premarket notification filed by The Du Pont Co. with the FDA for Du Pont Analyst Thyroid Rotor.
| Device ID | K884169 |
| 510k Number | K884169 |
| Device Name: | DU PONT ANALYST THYROID ROTOR |
| Classification | Ammonium Molybdate And Ammonium Vanadate, Phospholipids |
| 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 | CEL |
| CFR Regulation Number | 862.1575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1989-01-24 |