Response Biomedical Corp.
Vancouver British Columbia, CA
Response Biomedical Corp. appears in FDA device records in Vancouver British Columbia, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Response Biomedical Corp. between 2001 and 2009. The busiest year on record is 2004, with 2. The most recent is 2009, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093116 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAY | PSZ | Substantially Equivalent | |
| K091235 | RAMP RSV ASSAY | GQG | Substantially Equivalent | |
| K063662 | RAMP NT-PROBNP ASSAY | NBC | Substantially Equivalent | |
| K071591 | RAMP INFLUENZA A/B ASSAY | PSZ | Substantially Equivalent | |
| K033747 | RAMP CK-MB ASSAY | JHX | Substantially Equivalent | |
| K033745 | RAMP TROPONIN I ASSAY | MMI | Substantially Equivalent | |
| K012040 | RAMP MYOGLOBIN ASSAY | DDR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004205692 | 3004205692 | Response Biomedical Corp. | 1781-75th Avenue W., Vancouver British Columbia V6P 6P2 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- KHOFluorometer, For Clinical Use
- JHXFluorometric Method, Cpk Or Isoenzymes
- MMIImmunoassay Method, Troponin Subunit
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- NBCTest, Natriuretic Peptide
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1461-2020 | 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 Usage: use in the quality control of cardiac marker assays run on the RAMP platform. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain