Identity
- Trade Name
- ReliOn™ 2CT A1C Meter FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, home-use FDA UDI
- Device Name
- The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes. FDA UDI
- Model / Reference
- 3055 FDA UDI
- Description
- The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes. FDA UDI
Identifiers
- Catalog Number
- 3055 FDA UDI
- Primary DI / UDI-DI
- 00681131403252 FDA UDI
- 510(k) Number
- K090413 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
ReliOn™ 2CT A1C Meter by Walmart Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) monitoring system IVD, home-use.
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- Well at Walgreens — WALGREEN CO. · Class II
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Cleared under the same submission
K090413 also covers:
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY
- A1CNow Self Check, 8ct. — Polymer Technology Systems
- A1CNow® Self Check Test System — Polymer Technology Systems
- A1CNow®+ Multi-Use Test System (10 count) — Polymer Technology Systems
- A1CNow®+ Multi-UseTest System (20 count) — Polymer Technology Systems
- TRUE+ A1CNow Self Check — Polymer Technology Systems
- Well at Walgreens — WALGREEN CO.
- CVS Health At Home A1C Test Kit — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- CVS Health At Home A1C Test Kit — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
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
- Walmart Stores
Sources (1)
- FDA UDI 6e5c0a13-7d3e-4899-80f4-7283f455f5c9 37 fields · synced May 30, 2026