DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD

Enzyme Immunoassay, Diphenylhydantoin

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 Du Pont Dimension(r) Phenytoin (ptn) Method.

Pre-market Notification Details

• Device ID: K911056
• 510k Number: K911056
• Device Name: DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
• Classification: Enzyme Immunoassay, Diphenylhydantoin
• Applicant: E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 Wilmington, DE 19880
• Contact: Richard M Vaught
• Correspondent: Richard M Vaught; E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 Wilmington, DE 19880
• Product Code: DIP
• CFR Regulation Number: 862.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-03-08
• Decision Date: 1991-04-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414596037	K911056	000
00842768005619	K911056	000