DIGOXIN FLEX(TM) REAGENT CARTRIDGE

Enzyme Immunoassay, Digoxin

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 Digoxin Flex(tm) Reagent Cartridge.

Pre-market Notification Details

• Device ID: K946153
• 510k Number: K946153
• Device Name: DIGOXIN FLEX(TM) REAGENT CARTRIDGE
• Classification: Enzyme Immunoassay, Digoxin
• 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: KXT
• CFR Regulation Number: 862.3320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-16
• Decision Date: 1995-02-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768005503	K946153	000