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Oh'Care Lite Smart Glucose control solution-Level 1
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Oh'Care Lite Smart Glucose control solution-Level 1 FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- blood glucose meter and test strip control solution level 1 FDA UDI
- Model / Reference
- IGM-1003F FDA UDI
- Description
- blood glucose meter and test strip control solution level 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809115906519 FDA UDI
- 510(k) Number
- K182286 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose 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
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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, control
Oh'Care Lite Smart Glucose control solution-Level 1 by OSANG HEALTHCARE Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, control.
- WowGoHealth Control Solution - GSH-BGM902 - Level 1 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class I
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- TRUE FOCUS — TRIVIDIA HEALTH, INC. · Class I
- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
- ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
- Assure® Prism Control Solution — ARKRAY USA, INC. · Class I
- FORA — FORA CARE INC. · Class I
Cleared under the same submission
K182286 also covers:
- OKRA Pro Glucose meter — OSANG HEALTHCARE Co., Ltd.
- OKRA Pro Glucose monitoring system starter kit — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose Test Strip — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose control solution-Level 3 — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose monitoring system — OSANG HEALTHCARE Co., Ltd.
- Oh'care Lite Smart Glucose Meter — OSANG HEALTHCARE Co., Ltd.
- Oh'care Lite Smart Glucose Test Strip — OSANG HEALTHCARE Co., Ltd.
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 I | Pending data |
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Manufacturer
- Manufacturer
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI 1a36cdb5-ffae-4c9a-90f8-9b87f09ab8ed 36 fields · synced May 30, 2026