510(k) K884169

DU PONT ANALYST THYROID ROTOR by The DU Pont Co. — Product Code CEL

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