Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K061990 ↗

FDA Product Code

DCF

Models / Variants

Dimension Vista Microalbumin Flex Reagent Cartridge

Protein 3 Calibrator

Protein 3 Control

Device Class

Class II

Regulation

21 CFR Part 866.5040

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class I

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See all devices from Dade Behring, Inc. →