FDA Registration
Active
🇺🇸 United States
PreVantage CardioChek Plus Product Solution
Reg #: 3015525148
·
FEI: 3002698769
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- Polymer Technology Systems
- Registration Number
- 3015525148
- FEI Number
- 3002698769
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4600 Anson Boulevard
- City
- Whitestown
- State
- IN
- ZIP
- 46075
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182781
Owner / Operator
- Firm Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Operator Number
- 9031081
- Address
- 4600 Anson Blvd.
- City
- Whitestown
- State
- IN
- Postal Code
- 46075
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2019-02-12 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2019-02-12 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2019-02-12 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2019-02-12 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2019-02-12 |
Proprietary Names
PreVantage CardioChek Plus Product Solution
PreVantage Product Solutions
PreVantage A1CNow+ Product Solution
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility