510(k) K833385
K833385 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "N-ACETYLPROCAINAMIDE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 16, 1983. The device falls under product code DLG (Coating, Liquid, Glc), a Class I device regulated under 21 CFR 862.2250. 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
- December 16, 1983
- Date Received
- September 29, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Liquid, Glc
- Device Class
- Class I
- Regulation Number
- 862.2250
- Review Panel
- TX
- Submission Type