Data / Medical devices / Canada / Response Biomedical Corp.
Response Biomedical Corp.: FDA-registered device maker in Vancouver British Columbia, Canada, 6 510(k) clearances
Response Biomedical Corp. is registered with the FDA (registration 3004205692) in Vancouver British Columbia, Canada. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 24, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004205692
- Address
- 1781-75th Avenue W., Vancouver British Columbia, Canada, V6P 6P2
- Owner or operator
- Response Biomedical Corp. (9046777)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 15, 2004
- Registered through
- 2026
- Brand names listed
- RAMP Cardiac Controls, RAMP® 200, RAMP® CK-MB, RAMP® Myoglobin, RAMP® NT-proBNP, RAMP® RSV, RAMP® RSV Control Swabs, RAMP® Reader and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | 1 | Manufacturer | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Manufacturer | accessdata.fda.gov |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | 2 | Manufacturer | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Myoglobin, Antigen, Antiserum, Control | DDR | 2 | Manufacturer | accessdata.fda.gov |
| Test, Natriuretic Peptide | NBC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2009 | K091235 | RAMP RSV ASSAY | GQG | Substantially Equivalent | Response Biomedical Corp. | accessdata.fda.gov |
| July 21, 2008 | K063662 | RAMP NT-PROBNP ASSAY | NBC | Substantially Equivalent | Response Biomedical Corp. | accessdata.fda.gov |
| June 2, 2008 | K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| May 17, 2004 | K033747 | RAMP CK-MB ASSAY | JHX | Substantially Equivalent | Response Biomedical Corp. | accessdata.fda.gov |
| May 17, 2004 | K033745 | RAMP TROPONIN I ASSAY | MMI | Substantially Equivalent | Response Biomedical Corp. | accessdata.fda.gov |
| December 18, 2001 | K012040 | RAMP MYOGLOBIN ASSAY | DDR | Substantially Equivalent | Response Biomedical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 15, 2019 | 84514 | Class II | Terminated | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product | The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months. | accessdata.fda.gov |
Compare with other makers
- All makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Myoglobin, Antigen, Antiserum, Control
- All makers of Test, Natriuretic Peptide
- All makers of Fluorometer, For Clinical Use
- All makers of Fluorometric Method, Cpk Or Isoenzymes
Updated July 24, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.