Device Listing 1168253010

Listing Summary#

Listing key
1168253010
Premarket submission
K182738
Device
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
Applicant
Hangzhou AllTest Biotech Co., Ltd.
Product code
DKZ
Decision date
2019-03-27