Red-Cell Count By Photometry
Red-Cell Count by Photometry is a laboratory instrument or system that uses photometric methods to count red blood cells in a blood sample, providing a key parameter in the complete blood count (CBC) used in the diagnosis and monitoring of anemia, polycythemia, and other hematological conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKZ, regulated under 21 CFR 864.7100, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LKZ
- Device Class
- FDA class 2
- Regulation Number
- 864.7100
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.