Atlas FDA

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

FDA 510(k) clearance K061719 · decided 2006-08-25

Clearance details

K-number
K061719
Device name
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2006-06-19
Decision date
2006-08-25
Days to decision
67 days
Clearance type
Traditional
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SM recall (Z-3065-2024)Siemens Healthcare Diagnostics, Inc.2024-09-06

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02