Biotecx Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K982298 | OPTICOAT T4 EIA KIT | February 3, 1999 |
| K981824 | OPTICOAT T3 EIA KIT | December 22, 1998 |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | October 19, 1989 |
| K893620 | T3 CLASP-BEAD EIA KIT | August 11, 1989 |
| K892853 | T4 CLASP-BEAD EIA KIT | May 22, 1989 |
| K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE | October 31, 1988 |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | April 13, 1987 |
| K863188 | HPL RIA KIT | September 25, 1986 |
| K854876 | ALDOSTERONE DIRECT RIA KIT | March 17, 1986 |
| K851540 | ESTRADIOL DIRECT RIA KIT | June 6, 1985 |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | February 1, 1985 |
| K842957 | CORITSOL PREMIX RIA KIT | September 14, 1984 |
| K842555 | DHEA-S DIRECT RIA KIT | August 7, 1984 |
| K841333 | PROGESTERONE DIRECT RIA KIT-RADIOIMM | May 2, 1984 |
| K780761 | ELECTRO-PLETHYSMOGRAPH | June 30, 1978 |