Pantex, Div. Bio-Analysis, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Pantex, Div. Bio-Analysis, Inc.” (first 1981, latest 2012), across 13 product codes in 1 review panel. 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 | 1 | 587 |
| 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| CHP | Radioimmunoassay, Estradiol | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (16)
Most recent Pantex, Div. Bio-Analysis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | NHG | 2012-05-08 | 587 |
| K942658 | NEOSCREEN ELISA TSH | JLW | 1995-02-24 | 263 |
| K914107 | PROLACTIN IRMA IMMUNOMAG | CFT | 1991-09-30 | 17 |
| K912804 | FSH IRMA IMMUNOMAG | CGJ | 1991-08-12 | 48 |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | JLX | 1991-06-18 | 54 |
| K911050 | LH IRMA IMMUNOMAG | CEP | 1991-04-12 | 35 |
| K910717 | PANTEX IRMA LH 1251 KIT | CEP | 1991-03-19 | 27 |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | JLS | 1989-09-08 | 93 |
| K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT | CDZ | 1987-01-14 | 198 |
| K862447 | PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT | KHQ | 1986-10-07 | 102 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pantex, Div. Bio-Analysis, 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.
- Pantex (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pantex, Div. Bio-Analysis, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Pantex, Div. Bio-Analysis, Inc.” (first 1981, latest 2012), across 13 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pantex, Div. Bio-Analysis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pantex, Div. Bio-Analysis, Inc. is 51 days.
Which FDA product codes appear under Pantex, Div. Bio-Analysis, Inc.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); CEP (Radioimmunoassay, Luteinizing Hormone, 2); CHP (Radioimmunoassay, Estradiol, 2).
Next steps
- See all 16 Pantex, Div. Bio-Analysis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Pantex, Div. Bio-Analysis, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.