Identity
- Trade Name
- CURO L7 Analyzer FDA UDI
- Generic Name
- Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry FDA UDI
- Model / Reference
- 99LA10G-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809319396161 FDA UDI
- 510(k) Number
- K160282 FDA UDI
- FDA Product Code
- NBW FDA UDICHH FDA UDIJGY FDA UDILBR FDA UDI
- GMDN Term
- Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1175 FDA UDI862.1705 FDA UDI862.1475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
CURO L7 Analyzer by Sd Biosensor — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry.
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
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- JAS Diagnostics — Drew Scientific , Ltd. · Class II
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Cleared under the same submission
K160282 also covers:
- CURO L7 Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Analyzer — Sd Biosensor
- STANDARD™ LipidoCare Analyzer — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sd Biosensor
Sources (1)
- FDA UDI f6f7301f-53c3-4bcf-95cc-53c6b280d592 33 fields · synced May 30, 2026