510(k) K833385

N-ACETYLPROCAINAMIDE CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code DLG

K833385 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "N-ACETYLPROCAINAMIDE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 16, 1983. The device falls under product code DLG (Coating, Liquid, Glc), a Class I device regulated under 21 CFR 862.2250. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1983
Date Received
September 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Liquid, Glc
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type