Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
FDA 510(k) K182886 · Beckman Coulter
510(k) numberK182886
Submission
- Device name
- Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
- Applicant
- Beckman Coulter
Miami, FL, US - Received
- October 15, 2018
- Decision date
- September 6, 2019
- 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 Cytomics FC 500 Series (MPL or MCL) Flow Cytometer cleared by the FDA?
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer (K182886) received a 510(k) decision of Substantially Equivalent on September 6, 2019, 326 days after the submission was received.
What is the product code of K182886?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.