FDA Registration
Active
🇺🇸 United States
LipidPlus Professional Lipid Profile and Glucose Measuring System
Reg #: 2030633
·
FEI: 3000210620
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- JANT PHARMACAL CORP.
- Registration Number
- 2030633
- FEI Number
- 3000210620
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 16530 Ventura Blvd Ste 512
- City
- ENCINO
- State
- CA
- ZIP
- 91436
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130295
Owner / Operator
- Firm Name
- JANT PHARMACAL CORP.
- Operator Number
- 9024922
- Address
- 16530 VENTURA BLVD.,, SUITE 512
- City
- Encino
- State
- CA
- Postal Code
- 91436
- Country
- US
- Correspondent
- JACK L TAWFIK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2014-04-21 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2014-04-21 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2014-04-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-04-21 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2014-04-21 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2014-04-21 |
Proprietary Names
LipidPlus Professional Lipid Profile and Glucose Measuring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198