DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

Panels, Test, Susceptibility, Antimicrobial

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dried Gram-negative And Gram-positive Mic/combo Panels.

Pre-market Notification Details

• Device ID: K010418
• 510k Number: K010418
• Device Name: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
• Classification: Panels, Test, Susceptibility, Antimicrobial
• Applicant: DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691
• Contact: Cynthia Van Duker
• Correspondent: Cynthia Van Duker; DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691
• Product Code: LTT
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-02-12
• Decision Date: 2001-08-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590704056	K010418	000
15099590658007	K010418	000
15099590657956	K010418	000