Device class
Class II
Regulation 864.5260
Total clearances
5
2020-10-02 → 2025-06-27
Classification details
Medical specialty
Hematology
Regulation number
864.5260
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 85007 |
CPT
|
— |
Medium
|
Automated cell counting/differentiation device; component of hematology automation |
Pulse
Most recent 510(k) clearances