Pantex, Div. Bio-Analysis, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 16
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | May 8, 2012 |
| K942658 | NEOSCREEN ELISA TSH | February 24, 1995 |
| K914107 | PROLACTIN IRMA IMMUNOMAG | September 30, 1991 |
| K912804 | FSH IRMA IMMUNOMAG | August 12, 1991 |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | June 18, 1991 |
| K911050 | LH IRMA IMMUNOMAG | April 12, 1991 |
| K910717 | PANTEX IRMA LH 1251 KIT | March 19, 1991 |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | September 8, 1989 |
| K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT | January 14, 1987 |
| K862447 | PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT | October 7, 1986 |
| K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT | September 25, 1986 |
| K854324 | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT | December 5, 1985 |
| K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS | October 15, 1985 |
| K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO | October 15, 1985 |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | October 4, 1985 |
| K810204 | 17B ESTRADIOL | March 27, 1981 |