FDA Registration
Active
🇺🇸 United States
ReliOn Premier Compact Blood Glucose Monitoring System
Reg #: 1832816
·
FEI: 1832816
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ARKRAY FACTORY USA, INC.
- Registration Number
- 1832816
- FEI Number
- 1832816
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- ZIP
- 33122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120759
Owner / Operator
- Firm Name
- ARKRAY, INC.
- Operator Number
- 8030316
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- Postal Code
- 33122
- Country
- US
- Correspondent
- TOM - SPEIKERS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2018-08-30 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2018-08-30 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-08-30 |
Proprietary Names
ReliOn Premier Compact Blood Glucose Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198