Agen Biomedical , Ltd.
Agen Biomedical , Ltd. appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 14, 1999.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | December 14, 1999 |
| K974596 | DIMERTEST LATEX ASSAY | May 26, 1998 |
| K945642 | AGEN DIMERTEST GOLD EIA | October 25, 1995 |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | April 12, 1991 |
| K890189 | AGEN DIMERTEST EIA | March 3, 1989 |
| K882944 | DIMERTEST(R) LATEX | August 17, 1988 |