Theratest Laboratories, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Theratest Laboratories, Inc.” (first 1991, latest 2010), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 108 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 6 | 6 |
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 2 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | 2 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 | 1 |
| MID | System, Test, Anticardiolipin Immunological | 1 | 1 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 1 | 1 |
Plus 3 more product codes.
Review panels
- Immunology (21)
- Hematology (1)
Most recent Theratest Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090753 | THERATEST EL-ANTI-CCP/2 | NHX | 2010-03-05 | 350 |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | JZO | 2009-09-03 | 164 |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | MVM | 2007-11-05 | 138 |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | MOB | 2006-07-20 | 64 |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | MID | 2006-02-07 | 15 |
| K051066 | THERATEST EL-ANA PROFILES | LKP | 2005-10-07 | 164 |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | LJM | 2004-03-11 | 34 |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | MQA | 2003-02-06 | 62 |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | LJM | 2003-02-06 | 62 |
| K002559 | EL-ANA PROFILES-2K1 | LJM | 2000-09-12 | 26 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Theratest Laboratories, 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 Theratest Laboratories, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Theratest Laboratories, Inc.” (first 1991, latest 2010), across 13 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 Theratest Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theratest Laboratories, Inc. is 108 days.
Which FDA product codes appear under Theratest Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 6); DHR (System, Test, Rheumatoid Factor, 3); LLL (Extractable Antinuclear Antibody, Antigen And Control, 2).
Next steps
- See all 22 Theratest Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJM, Theratest Laboratories, 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.