510(k) K780944
K780944 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "LIQUID CHROMATOGRAPH MODEL 850". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), 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
- July 27, 1978
- Date Received
- June 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatography (Liquid, Gel), Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2260
- Review Panel
- TX
- Submission Type