DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

Diazo Colorimetry, Bilirubin

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Tbil Flex Reagent Cartridge, And Dimension Vista Tbil/dbil Calibrator; Models K1167, Kc212.

Pre-market Notification Details

• Device ID: K061719
• 510k Number: K061719
• Device Name: DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
• Classification: Diazo Colorimetry, Bilirubin
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 -6101
• Contact: George W Plummer
• Correspondent: George W Plummer; DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 -6101
• Product Code: CIG
• CFR Regulation Number: 862.1110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-19
• Decision Date: 2006-08-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768015717	K061719	000