510(k) K884169
K884169 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "DU PONT ANALYST THYROID ROTOR". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code CEL (Ammonium Molybdate And Ammonium Vanadate, Phospholipids), a Class I device regulated under 21 CFR 862.1575. The DU Pont Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1989
- Date Received
- October 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ammonium Molybdate And Ammonium Vanadate, Phospholipids
- Device Class
- Class I
- Regulation Number
- 862.1575
- Review Panel
- CH
- Submission Type