Company ยท US
Pantex, Div. Bio-Analysis, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2012. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| CHP | Radioimmunoassay, Estradiol | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2012 | K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY Pantex, Div. Bio-Analysis, Inc. | NHG |
| Feb 24, 1995 | K942658 | NEOSCREEN ELISA TSH Pantex, Div. Bio-Analysis, Inc. | JLW |
| Sep 30, 1991 | K914107 | PROLACTIN IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. | CFT |
| Aug 12, 1991 | K912804 | FSH IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. | CGJ |
| Jun 18, 1991 | K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT Pantex, Div. Bio-Analysis, Inc. | JLX |
| Apr 12, 1991 | K911050 | LH IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. | CEP |
| Mar 19, 1991 | K910717 | PANTEX IRMA LH 1251 KIT Pantex, Div. Bio-Analysis, Inc. | CEP |
| Sep 8, 1989 | K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | JLS |
| Jan 14, 1987 | K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | CDZ |
| Oct 7, 1986 | K862447 | PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | KHQ |
| Sep 25, 1986 | K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | CGR |
| Dec 5, 1985 | K854324 | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | CDX |
| Oct 15, 1985 | K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS Pantex, Div. Bio-Analysis, Inc. | CHP |
| Oct 15, 1985 | K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO Pantex, Div. Bio-Analysis, Inc. | CDZ |
| Oct 4, 1985 | K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY Pantex, Div. Bio-Analysis, Inc. | JKC |
| Mar 27, 1981 | K810204 | 17B ESTRADIOL Pantex, Div. Bio-Analysis, Inc. | CHP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||