FDA Registration
Active
🇺🇸 United States
SC-101M HDL Cholesterol Intermediate
Reg #: 1825740
·
FEI: 1825740
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Analytical Control Systems
- Registration Number
- 1825740
- FEI Number
- 1825740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9058 Technology Drive
- City
- Fishers
- State
- IN
- ZIP
- 46038
- Country
- US
Regulatory Submissions
- 510(k) Number
- K904767
Owner / Operator
- Firm Name
- ANALYTICAL CONTROL SYSTEMS
- Operator Number
- 1825740
- Address
- 9058 TECHNOLOGY DR., --
- City
- Fishers
- State
- IN
- Postal Code
- 46038
- Country
- US
- Correspondent
- Eric A BONDERMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2013-12-24 |
Proprietary Names
SC-101M HDL Cholesterol Intermediate
SC-101 HDL Cholesterol Normal
SC-101EL HDL Cholesterol Elevated
Establishment Types
Manufacture Medical Device