Data / Medical devices / United States / Catachem, Inc.
Catachem, Inc.: FDA-registered device maker in Oxford, CT, United States, 1 510(k) clearance
Catachem, Inc. is registered with the FDA (registration 2434178) in Oxford, CT, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2434178
- Address
- 353 Christian St Ste 2, Oxford, CT, United States, 06478
- Owner or operator
- CATACHEM, INC. (2434178)
- Roles
- Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- Catachem, DiscretPak
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Primary | JIS | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Cholyglycine, Bile Acids | KWW | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | 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 |
|---|---|---|---|---|---|---|
| January 19, 2007 | K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | KWW | Substantially Equivalent | Catachem, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Radioimmunoassay, Cholyglycine, Bile Acids
- All makers of Calibrator, Primary
Updated January 19, 2007. 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.