FDA Registration
Active
🇺🇸 United States
CHEMATICS, INC.
Reg #: 1825396
·
FEI: 1825396
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- CHEMATICS, INC.
- Registration Number
- 1825396
- FEI Number
- 1825396
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HWY. 13 SOUTH
- City
- NORTH WEBSTER
- State
- IN
- ZIP
- 46555
- Country
- US
Regulatory Submissions
- 510(k) Number
- K864159
Owner / Operator
- Firm Name
- CHEMATICS, INC.
- Operator Number
- 1825396
- Address
- PO BOX 293, 4519 STATE RD. 13 SOUTH
- City
- North Webster
- State
- IN
- Postal Code
- 46555
- Country
- US
- Correspondent
- Ellesha Hughes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2007-12-31 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2012-09-17 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-12-31 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2017-02-27 |
Proprietary Names
Chemcard Cholesterol Test
ALCO-SCREEN 02
Chemcard Glucose Test
ALCO-SCREEN
Telimmune Uno
Telimmune Duo
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198