Steller CD61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter

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

510(k) Number

K000611 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the primary function of the Steller CD61 Assay?

  The Steller CD61 Assay is a differential cell counter used for hematological analysis. It is specifically engineered to perform these measurements when used in conjunction with the Imagn 2000 Microvolume Fluorimeter.

• Is this device authorized for use in the United States?

  Yes, the Steller CD61 Assay is authorized under FDA 510(k) clearance K000611. It is classified as a Class 2 medical device under regulation number 864.5220.

• Can the Steller CD61 Assay be used on other fluorimeters?

  No, the assay is designed specifically for operation on the Imagn 2000 Microvolume Fluorimeter. Using it with other equipment may not provide the intended hematological analysis results.