14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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SEKURE Acetaminophen L3K Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·February 1, 2017
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·March 23, 2016