DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H

Calibrator, Multi-analyte Mixture

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H.

Pre-market Notification Details

• Device ID: K072435
• 510k Number: K072435
• Device Name: DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714
• Contact: Kathleen Ennis
• Correspondent: Kathleen Ennis; DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-30
• Decision Date: 2007-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768006449	K072435	000