510(k) K950180
K950180 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code DLI (Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase), a Class I device regulated under 21 CFR 862.3240. 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 15, 1995
- Date Received
- January 17, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- Device Class
- Class I
- Regulation Number
- 862.3240
- Review Panel
- TX
- Submission Type