Data / Medical devices / United States / Chematics, Inc.
Chematics, Inc.: FDA-registered device maker in North Webster, IN, United States, 4 510(k) clearances
Chematics, Inc. is registered with the FDA (registration 1825396) in North Webster, IN, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 22, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1825396
- Address
- Hwy. 13 South, North Webster, IN, United States, 46555
- Owner or operator
- CHEMATICS, INC. (1825396)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- December 31, 2007
- Registered through
- 2026
- Brand names listed
- ALCO-SCREEN, ALCO-SCREEN 02, Chemcard Cholesterol Test, Chemcard Glucose Test, Telimmune Duo, Telimmune Uno
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 22, 2013 | K121247 | ALCO-SCREEN | DIC | Substantially Equivalent | Chematics, Inc. | accessdata.fda.gov |
| September 12, 2012 | K121256 | ALCO-SCREEN 02 | DIC | Substantially Equivalent | Chematics, Inc. | accessdata.fda.gov |
| July 23, 1996 | K943503 | CHEMCARD GLUCOSE TEST | CGA | Substantially Equivalent | Chem-Elec, Inc. | accessdata.fda.gov |
| June 10, 1988 | K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD | CHH | Substantially Equivalent | Chem-Elec, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
- All makers of Glucose Oxidase, Glucose
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated March 22, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.