Response Biomedical Corp.
FDA Regulatory Profile
Response Biomedical Corp. appears in FDA public data with 1 recall, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1461-2020, Class II) was initiated on March 15, 2019. Its most recent 510(k) clearance was granted on October 21, 2009.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1461-2020 | Class II | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedica | March 15, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K093116 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAY | October 21, 2009 |
| K091235 | RAMP RSV ASSAY | July 24, 2009 |
| K063662 | RAMP NT-PROBNP ASSAY | July 21, 2008 |
| K071591 | RAMP INFLUENZA A/B ASSAY | April 16, 2008 |
| K033747 | RAMP CK-MB ASSAY | May 17, 2004 |
| K033745 | RAMP TROPONIN I ASSAY | May 17, 2004 |
| K012040 | RAMP MYOGLOBIN ASSAY | December 18, 2001 |