3 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
FDA 510(k)
FDA Class 1
·General Hospital
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
FDA 510(k)
FDA Class 2
·General Hospital
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.
FDA Enforcement
Class II
·Terminated·Response Biomedical Corp.·March 18, 2020