Texas Intl. Laboratories, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Texas Intl. Laboratories, Inc.” (first 1983, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 4 | 4 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| JJO | Flame Emission Photometer For Clinical Use | 1 | 1 |
| KQG | Instrument, Coagulation | 1 | 1 |
Review panels
- Hematology (7)
- Clinical Chemistry (3)
Most recent Texas Intl. Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953643 | HEMATIL 18 (H-18) | GKZ | 1996-03-22 | 231 |
| K904031 | CHEMA CHOL CHOLESTEROL SYSTEM | CHH | 1991-03-11 | 192 |
| K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | KQG | 1990-04-16 | 63 |
| K900684 | RDW AND MPV INDICES ON HEMAT 12 | GKZ | 1990-04-16 | 63 |
| K884006 | HEMAT 12 | GKZ | 1988-12-05 | 75 |
| K883177 | H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER | GKZ | 1988-11-30 | 126 |
| K853722 | PLT-4 PLATELET ANALYZER | GKL | 1986-01-17 | 134 |
| K832886 | FLAME PHOTOMETER T281-T282-T283 | JJO | 1983-12-08 | 104 |
| K832890 | HEMACOMP 7 OR HEMATIL 7 | GKL | 1983-10-19 | 54 |
| K831649 | THERMOMIXER S213-PHOTOANALYZER S263 | JJE | 1983-08-24 | 93 |
Recalls
openFDA lists no recalls under a recalling firm named Texas Intl. 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.
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 Immunology, Inc. (27 510(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 Intl. Laboratories, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Texas Intl. Laboratories, Inc.” (first 1983, latest 1996), 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 Texas Intl. Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Texas Intl. Laboratories, Inc. is 98 days.
Which FDA product codes appear under Texas Intl. Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 4); GKL (Counter, Cell, Automated (Particle Counter), 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1).
Next steps
- See all 10 Texas Intl. Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Texas Intl. 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.