DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

Calibrator, Primary

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Total Iron Binding Capacity Calibrator.

Pre-market Notification Details

• Device ID: K061251
• 510k Number: K061251
• Device Name: DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
• Classification: Calibrator, Primary
• Applicant: DADE BEHRING, INC. BLDG 500; M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Contact: Lorraine H Piestrak
• Correspondent: Lorraine H Piestrak; DADE BEHRING, INC. BLDG 500; M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Product Code: JIS
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-04
• Decision Date: 2006-05-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768015847	K061251	000