K884169 is an FDA 510(k) clearance for the DU PONT ANALYST THYROID ROTOR. This device is classified as a Ammonium Molybdate And Ammonium Vanadate, Phospholipids (Class I - General Controls, product code CEL).
Submitted by The DU Pont Co. (Wilmington, US). The FDA issued a Cleared decision on January 24, 1989, 112 days after receiving the submission on October 4, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1575.
| 510(k) Number | K884169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1988 |
| Decision Date | January 24, 1989 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEL — Ammonium Molybdate And Ammonium Vanadate, Phospholipids |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1575 |