510(k) K781941

ANALYSIS SYSTEM, PREP SAMPLE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DOZ

K781941 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ANALYSIS SYSTEM, PREP SAMPLE". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code DOZ (Liquid Chromatography, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. 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
January 3, 1979
Date Received
November 20, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liquid Chromatography, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type