DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM

Acid Phosphatase, Thymolphthale Inmonophosphate

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 Dimension (tm) Clinical Chemistry System.

Pre-market Notification Details

• Device ID: K864230
• 510k Number: K864230
• Device Name: DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
• Classification: Acid Phosphatase, Thymolphthale Inmonophosphate
• Applicant: E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898
• Contact: Grace H Singles
• Correspondent: Grace H Singles; E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898
• Product Code: CKE
• CFR Regulation Number: 862.1020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-28
• Decision Date: 1986-11-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768005275	K864230	000
00842768005039	K864230	000