110 results
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62ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACON COMBO PREGNANCY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
On Call Express Mobile Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ON CALL PLUS DIABETES MONITORING SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUIK-CHECK HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ON CALL CHOSEN LANCING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Flowflex COVID-19 Antigen Home Test
FDA 510(k)
FDA Class 2
·Microbiology
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Flowflex Plus COVID-19 + Flu A/B Home Test
FDA 510(k)
FDA Class 2
·Microbiology
ACON MIDSTREAM PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
On Call Express Pro Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry