FDA Registration
Active
🇺🇸 United States
Hemoglobin A1c Reagent Set
Reg #: 3005146313
·
FEI: 3005146313
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SANZAY CORPORATION -
- Registration Number
- 3005146313
- FEI Number
- 3005146313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1080 NW 163rd Drive
- City
- Miami Gardens
- State
- FL
- ZIP
- 33169
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051200
Owner / Operator
- Firm Name
- Sanzay Corporation - Integrated Diagnostics Group
- Operator Number
- 10026301
- Address
- 1080 NW 163RD DRIVE
- City
- Miami Gardens
- State
- FL
- Postal Code
- 33169
- Country
- US
- Correspondent
- Maria R Sanchez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2018-09-10 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-09-10 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2018-09-10 |
Proprietary Names
Hemoglobin A1c Reagent Set
Establishment Types
Repack or Relabel Medical Device