Device class
Class I
Regulation 862.1175
Total clearances
3
2022-06-30 → 2025-12-30
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1175
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 |
| 82465 |
CPT
|
— |
High
|
Standard CPT for total cholesterol enzymatic method (esterase-oxidase) |
| 82607 |
CPT
|
— |
Medium
|
Cholesterol enzymatic assay; standard codes are 82465 (total) or 82480 (HDL) |
Pulse
Most recent 510(k) clearances