Device class
Class II
Regulation 864.7415
Total clearances
3
2022-04-19 → 2024-04-04
Classification details
Medical specialty
Hematology
Regulation number
864.7415
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Sebia
|
1 |
0 |
2024-04-04 |
|
Trinity Biotech (Primus Corporation, Dba Trinity Biotech) |
1 |
0 |
2023-08-04 |
|
Helena Laboratories, Corp.
|
1 |
0 |
2022-04-19 |
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 |
| 83026 |
CPT
|
— |
High
|
CPT code for hemoglobin, abnormal, quantitation |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-04-04 |
K232027 |
Sebia
|
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument |
| 2023-08-04 |
K222635 |
Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
|
Premier Resolution System |
| 2022-04-19 |
K192931 |
Helena Laboratories, Corp.
|
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control |