Texas Immunology, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Texas Immunology, Inc.” (first 1982, latest 1999), across 18 product codes in 4 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 | 3 |
| KTN | System, Test, Infectious Mononucleosis | 3 | 3 |
| DCN | System, Test, C-Reactive Protein | 2 | 2 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 2 | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (8)
- Immunology (8)
- Microbiology (8)
- Clinical Toxicology (3)
Most recent Texas Immunology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991465 | DRUG STOP | MVO | 1999-12-10 | 227 |
| K980153 | DRUG CHECK | DIO | 1998-03-27 | 70 |
| K973208 | FIRST SIGN | LCX | 1997-10-20 | 54 |
| K972094 | TARGET CARDIAC TROPONIN I TEST | MMI | 1997-07-23 | 49 |
| K963680 | TARGET MYOGLOBIN TEST | DDR | 1997-02-06 | 143 |
| K912246 | TARGET MICROALBUMINURIA TEST | JIR | 1991-07-19 | 59 |
| K910073 | TARGET ASO TEST | GTQ | 1991-05-21 | 132 |
| K904105 | V-TREND TARGET RF TEST | DHR | 1990-10-15 | 39 |
| K892231 | V-TREND TARGET CRP TEST | DCN | 1989-04-21 | 17 |
| K890423 | V-TREND TARGET CRP TEST | DCK | 1989-02-17 | 22 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Texas Immunology, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Texas Medical Products, Inc. (30 510(k)s)
- Texas Intl. Laboratories, Inc. (10 510(k)s)
- Texas Instruments, Inc. (3 510(k)s)
- Texas Applied Biomedical Services, Inc. (2 510(k)s)
- Texas Airsonics, Inc. (1 510(k)s)
- Texas Bio Scan (1 510(k)s)
- Texas Dynamics (1 510(k)s)
- Texas Infrared (1 510(k)s)
- Texas Innovative Medical Devices (Dba) Skeletal (1 510(k)s)
- Texas Institute For Conservative Dentistry (1 510(k)s)
- Texas Medical Devices, Inc. (1 510(k)s)
- Texas Medical Electronics Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Texas Immunology, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Texas Immunology, Inc.” (first 1982, latest 1999), across 18 product codes in 4 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 Texas Immunology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Texas Immunology, Inc. is 49 days.
Which FDA product codes appear under Texas Immunology, Inc.?
The most frequent FDA product codes under this applicant name are DHR (System, Test, Rheumatoid Factor, 3); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 3); KTN (System, Test, Infectious Mononucleosis, 3).
Next steps
- See all 27 Texas Immunology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHR, Texas Immunology, 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.