Chembio Diagnostic Systems
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 5
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | June 3, 2020 |
| K011550 | HCG STAT PAK ULTRA-FAST | August 14, 2001 |
| K011551 | SURE CHECK PREGNANCY TEST | August 14, 2001 |
| K010244 | SURE CHECK OVULATION PREDICTOR | May 2, 2001 |
| K981913 | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY | February 12, 1999 |
| K961965 | SURE CHECK PREGNANCY TEST | June 24, 1996 |
| K923925 | HCG STAT-PAK | December 24, 1992 |