Data / Medical devices / United States / Calbiotech, Inc.
Calbiotech, Inc.: FDA-registered device maker in El Cajon, CA, United States, 1 510(k) clearance
Calbiotech, Inc. is registered with the FDA (registration 2090110) in El Cajon, CA, United States. It lists 21 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2090110
- FEI number
- 3002346973
- Address
- 1935 Cordell Ct, El Cajon, CA, United States, 92020
- Owner or operator
- Calbiotech, Inc. (9046880)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- November 16, 2006
- Registered through
- 2026
- Brand names listed
- 14-3-3 eta; FLAER, Calbiotech SAR Various, GENERAL PURPOSE, Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit, Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit, Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit, Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit, Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 17, 2013 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | DKZ | Substantially Equivalent | Advin Biotech | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 27, 2008 | 50691 | Not yet classified | Terminated | ANA IgG ELISA 96 Well Kit, Catalog Number: AN033G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to this recall, the recall was initiated because Calbiotech is fully committed to compliance with all State and Federal regulations. | accessdata.fda.gov |
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Updated June 17, 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.