Biogenex Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 12
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2113-2014 | Class II | InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. | July 1, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | March 8, 2002 |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | February 28, 2002 |
| K925189 | PREGNAGEN 1-STEP PREGNANCY TEST | January 6, 1993 |
| K902208 | MODIFIED OVUGEN | July 17, 1990 |
| K884880 | PREGNAGEN(TM) | January 13, 1989 |
| K882002 | PREGNAGEN(TM) | September 9, 1988 |
| K873534 | OVUGEN SURETEST | November 23, 1987 |
| K831221 | RIAGEN B-HCG RIA KIT | June 2, 1983 |
| K821657 | RIAGEN B-HCG RIA | July 13, 1982 |
| K821234 | RIAGEN B-HCG RIA | May 21, 1982 |
| K820724 | FLUOROGEN PAP FIA | April 14, 1982 |
| K813261 | RIAGEN PAP RIA | December 17, 1981 |