Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pantex, Div. Bio-Analysis, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
263 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 | 587 | 0 |
| K942658 | NEOSCREEN ELISA TSH | Pantex, Div. Bio-Analysis, Inc. | 1995-02-24 | 263 | 0 |
| K914107 | PROLACTIN IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-09-30 | 17 | 0 |
| K912804 | FSH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-08-12 | 48 | 0 |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-06-18 | 54 | 0 |
| K911050 | LH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-04-12 | 35 | 0 |
| K910717 | PANTEX IRMA LH 1251 KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-03-19 | 27 | 0 |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1989-09-08 | 93 | 0 |
| K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1987-01-14 | 198 | 0 |
| K862447 | PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1986-10-07 | 102 | 0 |
| K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1986-09-25 | 97 | 0 |
| K854324 | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1985-12-05 | 38 | 0 |
| K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS | Pantex, Div. Bio-Analysis, Inc. | 1985-10-15 | 28 | 0 |
| K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO | Pantex, Div. Bio-Analysis, Inc. | 1985-10-15 | 28 | 0 |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | 1985-10-04 | 17 | 0 |
| K810204 | 17B ESTRADIOL | Pantex, Div. Bio-Analysis, Inc. | 1981-03-27 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda