Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Response Biomedical with 7 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 15, 2019: Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Respon….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 15, 2019 | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318)Class II · The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB pro | Device recalls |
| Oct 21, 2009 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAYK093116 · PSZ | 510(k) clearances |
| Jul 24, 2009 | RAMP RSV ASSAYK091235 · GQG | 510(k) clearances |
| Jul 21, 2008 | RAMP NT-PROBNP ASSAYK063662 · NBC | 510(k) clearances |
| Apr 16, 2008 | RAMP INFLUENZA A/B ASSAYK071591 · PSZ | 510(k) clearances |
| May 17, 2004 | RAMP TROPONIN I ASSAYK033745 · MMI | 510(k) clearances |
| May 17, 2004 | RAMP CK-MB ASSAYK033747 · JHX | 510(k) clearances |
| Dec 18, 2001 | RAMP MYOGLOBIN ASSAYK012040 · DDR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
