DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137

Enzymatic, Carbon-dioxide

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Enzymatic Carbonate (eco2) Flex Method, Catalog Df137.

Pre-market Notification Details

• Device ID: K010206
• 510k Number: K010206
• Device Name: DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
• Classification: Enzymatic, Carbon-dioxide
• Applicant: DADE BEHRING, INC. GLASCO B500 M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Contact: Richard M Vaught
• Correspondent: Richard M Vaught; DADE BEHRING, INC. GLASCO B500 M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Product Code: KHS
• CFR Regulation Number: 862.1160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-23
• Decision Date: 2001-03-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768005374	K010206	000