Steller CD61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter
FDA 510(k) K000611 · Bd Biosciences
510(k) numberK000611
Submission
- Device name
- Steller CD61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter
- Applicant
- Bd Biosciences
San Jose, CA, US - Received
- February 23, 2000
- Decision date
- May 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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Questions and answers
When was Steller CD61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter cleared by the FDA?
Steller CD61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter (K000611) received a 510(k) decision of Substantially Equivalent on May 18, 2000, 85 days after the submission was received.
What is the product code of K000611?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.