Data / Medical devices / United States / Scantibodies Laboratory, Inc.
Scantibodies Laboratory, Inc.: FDA-registered device maker in Santee, CA, United States, 3 510(k) clearances
Scantibodies Laboratory, Inc. is registered with the FDA (registration 2020808) in Santee, CA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 20, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2020808
- Address
- 9336 Abraham Way, Santee, CA, United States, 92071
- Owner or operator
- Scantibodies Laboratory Inc. (2020808)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- January 24, 2006
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Campylobacter Spp. | LQP | 1 | Contract manufacturer | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Contract manufacturer | accessdata.fda.gov |
| Covid-19 Multi-Analyte Antigen Device | QMN | N | Contract manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Silica Gel, Tlc | DKS | 1 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Acth | CKG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| May 20, 2005 | K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | CKG | Substantially Equivalent | Scantibodies Laboratory, Inc. | accessdata.fda.gov |
| June 3, 2002 | K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | CKG | Substantially Equivalent | Scantibodies Laboratory, Inc. | accessdata.fda.gov |
| February 14, 1996 | K954247 | SYSCON CONTROL ASSAYED & UNASSAYED | JJY | Substantially Equivalent | Scantibodies Laboratory, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Radioimmunoassay, Acth
- All makers of Covid-19 Multi-Analyte Antigen Device
- All makers of Campylobacter Spp.
- All makers of Reagent, Borrelia Serological Reagent
Updated May 20, 2005. 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.