Biotecx Laboratories, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Biotecx Laboratories, Inc.” (first 1978, latest 1999), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | 1 |
| JMX | Ninhydrin, Nitrogen (Amino-Nitrogen) | 1 | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (14)
- Cardiovascular (1)
Most recent Biotecx Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982298 | OPTICOAT T4 EIA KIT | KLI | 1999-02-03 | 217 |
| K981824 | OPTICOAT T3 EIA KIT | CDP | 1998-12-22 | 214 |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | CGR | 1989-10-19 | 43 |
| K893620 | T3 CLASP-BEAD EIA KIT | CDP | 1989-08-11 | 92 |
| K892853 | T4 CLASP-BEAD EIA KIT | KLI | 1989-05-22 | 34 |
| K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE | KHQ | 1988-10-31 | 55 |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | JLS | 1987-04-13 | 18 |
| K863188 | HPL RIA KIT | JMX | 1986-09-25 | 37 |
| K854876 | ALDOSTERONE DIRECT RIA KIT | KQN | 1986-03-17 | 101 |
| K851540 | ESTRADIOL DIRECT RIA KIT | CHP | 1985-06-06 | 51 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biotecx 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 Biotecx Laboratories, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Biotecx Laboratories, Inc.” (first 1978, latest 1999), across 11 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 Biotecx Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotecx Laboratories, Inc. is 51 days.
Which FDA product codes appear under Biotecx Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are CDP (Radioimmunoassay, Total Triiodothyronine, 2); CGR (Radioimmunoassay, Cortisol, 2); JLS (Radioimmunoassay, Progesterone, 2).
Next steps
- See all 15 Biotecx Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDP, Biotecx 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.