# Scantibodies Laboratory, Inc.

- Location (FDA's records): Santee, CA
- FDA decisions: 19 (1995–2006): 19 510(k) clearances
- Product codes: CEW (10), JJY (3), JKR (2), CKG (2), JLW (1), MJX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)

## Its most-cited devices
- K955812: Syscon Turmor Marker Control (1996), cited by 1
- K001411: Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056 (2000), cited by 1

## Recent decisions
- K060578: Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version) (Aug 30, 2006)
- K060420: Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3KG002 (Mar 1, 2006)
- K060348: Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay Kit (Feb 27, 2006)
- K051888: Total Intact PTH Immunoradiometric Assay (Coated Tube Version), Model 3KG013 (Oct 18, 2005)
- K051810: Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014 (Sep 9, 2005)
- K051141: Whole PTH (1-84) Specific Immunochemiluminometric Assay (Icma), Model 3KG002 (Jul 26, 2005)
- K051150: Total Intact PTH Immunochemiluminometric (Icma) Assay Kit (Jul 26, 2005)
- K050748: Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011 (May 20, 2005)

Source page: https://510kreport.com/company/scantibodies-laboratory