510(k) K800516

DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. by E.I. Dupont DE Nemours & Co., Inc. — Product Code KIE

K800516 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.". The FDA issued a decision of Substantially Equivalent on March 19, 1980. The device falls under product code KIE (Apparatus, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. 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
March 19, 1980
Date Received
March 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, High Pressure Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type