510(k) K800516
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