Chrysalis Intelligence · Product Codes · DCK

DCK · C-Reactive Protein, Antigen, Antiserum, And Control

Immunology · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 866.5270
Total clearances
3
2020-06-25 → 2025-04-18
Last 12 months
0
Unique sponsors
3
Medical specialty
Immunology
Review panel
IM
Regulation number
866.5270
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Procise Diagnostics 1 0 2022-11-04
HORIBA ABX SAS 1 0 2020-06-25
Kamiya Biomedical Company, LLC 1 0 2025-04-18
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.

CodeTypeDescriptionConfidenceRationale
86140 CPT High C-reactive protein; quantitative standard immunology code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-04-18 K242170 Kamiya Biomedical Company, LLC K-ASSAY CRP (Ver.2)
2022-11-04 K201256 Procise Diagnostics Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
2020-06-25 K192028 HORIBA ABX SAS Yumizen C1200 CRP