510(k) Report

FDA applicant

Response Biomedical Corp.

Burnaby, British Columbia, CA7 decisions2001–20090 recalls

FDA records 7 decisions for Response Biomedical Corp. (Burnaby, British Columbia, CA) from 2001 to 2009: 7 510(k) clearances. Most are in product codes PSZ (Devices Detecting Influenza A, B, And C Virus…) and NBC (Test, Natriuretic Peptide). Its devices cite 12 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Response Biomedical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008: 22009: 2
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Response Biomedical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PSZDevices Detecting Influenza A, B, And C Virus Antigens2decisions
  • NBCTest, Natriuretic Peptide1decision
  • DDRMyoglobin, Antigen, Antiserum, Control1decision
  • JHXFluorometric Method, Cpk Or Isoenzymes1decision
  • GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus1decision
  • MMIImmunoassay Method, Troponin Subunit1decision

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071591Ramp Influenza a/B AssayResponse Biomedical Corp. · 20081cites it

What has FDA decided for it lately?

  • K093116Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp. · 2009
  • K091235Ramp RSV AssayResponse Biomedical Corp. · 2009
  • K063662Ramp NT-Probnp AssayResponse Biomedical Corp. · 2008
  • K071591Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
  • K033747Ramp CK-MB AssayResponse Biomedical Corp. · 2004
  • K033745Ramp Troponin I AssayResponse Biomedical Corp. · 2004
  • K012040Ramp Myoglobin AssayResponse Biomedical Corp. · 2001

All 7 as Response Biomedical Corp. →

Other applicant names beginning “Response”

FDA records each applicant name separately; these may or may not be the same firm.

Response Ortho Solutions, LLC 3