Scantibodies Laboratory, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Scantibodies Laboratory, Inc.” (first 1995, latest 2006), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | 10 | 10 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| CKG | Radioimmunoassay, Acth | 2 | 2 |
| JKR | Radioimmunoassay, Calcitonin | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| MJX | Kit, Serological, Positive Control | 1 | 1 |
Review panels
- Clinical Chemistry (18)
- Microbiology (1)
Most recent Scantibodies Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | JKR | 2006-08-30 | 177 |
| K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 | CEW | 2006-03-01 | 12 |
| K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | CEW | 2006-02-27 | 17 |
| K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 | CEW | 2005-10-18 | 98 |
| K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 | CEW | 2005-09-09 | 66 |
| K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | CEW | 2005-07-26 | 83 |
| K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 | CEW | 2005-07-26 | 83 |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | CKG | 2005-05-20 | 59 |
| K031534 | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 | CEW | 2003-07-30 | 75 |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | CKG | 2002-06-03 | 66 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scantibodies Laboratory, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Scantibodies Laboratory, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Scantibodies Laboratory, Inc.” (first 1995, latest 2006), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scantibodies Laboratory, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scantibodies Laboratory, Inc. is 83 days.
Which FDA product codes appear under Scantibodies Laboratory, Inc.?
The most frequent FDA product codes under this applicant name are CEW (Radioimmunoassay, Parathyroid Hormone, 10); JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); CKG (Radioimmunoassay, Acth, 2).
Next steps
- See all 19 Scantibodies Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEW, Scantibodies Laboratory, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.