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Liquid Frozen Lipid Control - Level 2 (liq Lpd Control 2)
FDA UDIFDA 510(k)EUDAMEDClass I (US FDA UDI)
510(k) K022591
Identity
- Trade Name
- LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) FDA UDI
- Generic Name
- Multiple lipid analyte IVD, control FDA UDI
- Model / Reference
- LE10175 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273215205 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple lipid analyte IVD, control
Liquid Frozen Lipid Control - Level 2 (liq Lpd Control 2) by Randox Laboratories, Ltd. — Class I — FDA_510K, IVDR — listed in FDA GUDID, FDA 510(k), EUDAMED
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Also classified as Multiple lipid analyte IVD, control.
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- Liquichek — Bio-Rad Laboratories · Class I
- Audit MicroControls Linearity FD Lipids — Aalto Scientific, Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022591 | Class I | Active |
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (3)
- FDA UDI ec30d79b-c03d-420a-bacf-6342070272ba 56 fields · synced Jun 18, 2026
- FDA 510(k) K022591 1 fields · synced Jun 4, 2026
- EUDAMED 1 fields · synced Jun 3, 2026