Chrysalis Intelligence · Product Codes · DFC

DFC · Unclassified

3 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
3
2022-12-22 → 2026-06-16
Last 12 months
1
Unique sponsors
3
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Roche Diagnostics Operations 1 0 2025-01-24
Diazyme Laboratories, Inc. 1 1 2026-06-16
SENTINEL CH. SpA 1 0 2022-12-22
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
83721 CPT High LDL cholesterol; lipoprotein measurement standard code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-16 K253069 Diazyme Laboratories, Inc. Lipoprotein (a) Molarity Assay
2025-01-24 K241220 Roche Diagnostics Operations Tina-quant Lipoprotein(a) Gen.2 Molarity
2022-12-22 K211058 SENTINEL CH. SpA Lp(a) Ultra