Scantibodies Laboratory Inc.
Santee, CA, US
SCANTIBODIES LABORATORY INC. appears in FDA device records in Santee, CA. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Scantibodies Laboratory Inc. between 1995 and 2006. The busiest year on record is 2005, with 5. The most recent is 2006, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 5 |
| 2006 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | JKR | Substantially Equivalent | |
| K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 | CEW | Substantially Equivalent | |
| K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | CEW | Substantially Equivalent | |
| K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 | CEW | Substantially Equivalent | |
| K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 | CEW | Substantially Equivalent | |
| K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | CEW | Substantially Equivalent | |
| K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 | CEW | Substantially Equivalent | |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | CKG | Substantially Equivalent | |
| K031534 | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 | CEW | Substantially Equivalent | |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | CKG | Substantially Equivalent | |
| K004038 | TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 | CEW | Substantially Equivalent | |
| K001411 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 | CEW | Substantially Equivalent | |
| K974262 | SYSCOS IDC - G, IDC, BSC, IDC - G | MJX | Substantially Equivalent | |
| K962464 | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) | JLW | Substantially Equivalent | |
| K961043 | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) | JKR | Substantially Equivalent | |
| K955812 | SYSCON TURMOR MARKER CONTROL | JJY | Substantially Equivalent | |
| K954247 | SYSCON CONTROL ASSAYED & UNASSAYED | JJY | Substantially Equivalent | |
| K944788 | INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) | CEW | Substantially Equivalent | |
| K942647 | COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI | JJY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3026664926 | 3026664926 | SCANTIBODIES LABORATORY INC. | 8005 Saint Andrews Ave, San Diego, CA 92154 US | 2026 | |
| 2020808 | 2020808 | SCANTIBODIES LABORATORY, INC. | 9336 ABRAHAM WAY, SANTEE, CA 92071 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- KXGApplicator, Absorbent Tipped, Sterile
- LQPCampylobacter Spp.
- NNIContainer, Specimen, Non-Sterile
- QKPCoronavirus Antigen Detection Test System.
- QMNCovid-19 Multi-Analyte Antigen Device
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- MJXKit, Serological, Positive Control
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DKSPlate, Silica Gel, Tlc
- CKGRadioimmunoassay, Acth
- JKRRadioimmunoassay, Calcitonin
- CEWRadioimmunoassay, Parathyroid Hormone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- LSRReagent, Borrelia Serological Reagent
- QKOReagent, Coronavirus Serological
- LLHReagents, Clostridium Difficile Toxin
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain