DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

Calibrators, Drug Specific

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Ecstasy Calibrator, Model Kc520.

Pre-market Notification Details

• Device ID: K062182
• 510k Number: K062182
• Device Name: DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
• Classification: Calibrators, Drug Specific
• Applicant: DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 Newark, DE 19714
• Contact: Victor M Carrio
• Correspondent: Victor M Carrio; DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 Newark, DE 19714
• Product Code: DLJ
• CFR Regulation Number: 862.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-31
• Decision Date: 2006-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768016486	K062182	000