110 results · 62ms · Sources: EU EUDAMED, US FDA

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