510(k) K904301

DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code DKJ

K904301 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD". The FDA issued a decision of Substantially Equivalent on November 9, 1990. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. 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
November 9, 1990
Date Received
September 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type