DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD

Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

E.I. DUPONT DE NEMOURS & CO., INC.

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Dimension(r) Pseudocholinesterase Method.

Pre-market Notification Details

• Device ID: K950180
• 510k Number: K950180
• Device Name: DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
• Classification: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
• Applicant: E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1158 Wilmington, DE 19880 -0022
• Contact: Cathy P Craft
• Correspondent: Cathy P Craft; E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1158 Wilmington, DE 19880 -0022
• Product Code: DLI
• CFR Regulation Number: 862.3240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-01-17
• Decision Date: 1995-03-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768014178	K950180	000