Identity
- Trade Name
- CURO L5 Total Cholesterol Strips FDA UDI
- Generic Name
- Glucose/ketone/lipid monitoring system IVD, home-use FDA UDI
- Device Name
- Total Cholesterol Strips FDA UDI
- Model / Reference
- CURO L5 Total Cholesterol Strips FDA UDI
- Description
- Total Cholesterol Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860394001256 FDA UDI
- 510(k) Number
- K130295 FDA UDI
- FDA Product Code
- NBW FDA UDICGA FDA UDICHH FDA UDIJGY FDA UDIJJX FDA UDILBR FDA UDI
- GMDN Term
- Glucose/ketone/lipid monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1175 FDA UDI862.1705 FDA UDI862.1660 FDA UDI862.1475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-careBlood glucose/blood pressure monitoring system, home-useGlucose analyser IVD, home-use
CURO L5 Total Cholesterol Strips by Kpi Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple physiological parameter spot-check system analyser.
- CURO L5 — KPI HEALTHCARE, INC. · Class II
- Curo L5 — KPI HEALTHCARE, INC. · Class I
Cleared under the same submission
K130295 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kpi Healthcare, Inc.
Sources (1)
- FDA UDI 3bd9e660-1303-4115-8589-7ce543467690 34 fields · synced May 30, 2026