Atlas FDA

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)

FDA 510(k) clearance K153465 · decided 2016-03-31

Clearance details

K-number
K153465
Device name
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
Applicant
Assure Tech. (Hangzhou) Co, Ltd.
Decision
Substantially Equivalent
Date received
2015-12-01
Decision date
2016-03-31
Days to decision
121 days
Clearance type
Traditional
Product code
DKZ
Device class
2
Regulation number
862.3100
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Hangzhou, CN
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Assure Tech. (Hangzhou) Co

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DRI Ecstasy Plus Assay (K240670)Microgenics Corporation2024-10-30
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (K233019)Hangzhou AllTest Biotech Co., Ltd.2023-12-13
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K231137)Xenta Biomedical Science Co., Ltd.2023-05-19
Quidel Triage® TOX Drug Screen, 94600 (K200363)Quidel Cardiovascular, Inc.2020-03-11
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (K191099)Atlas Medical2019-10-03
Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (K182719)Quidel Cardiovascular, Inc.2019-06-19
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) (K182738)Hangzhou AllTest Biotech Co., Ltd.2019-03-27
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use (K180879)Shanghai Venture Bio-Tech Co., Ltd.2018-12-14
QuickScreen Pro Multi Drug Screening Test, Model 9395Z (K181945)Phamatech, Inc.2018-10-18
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (K173303)Alfa Scientific Designs, Inc.2018-02-23
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (K161251)Hangzhou Clongene Biotech Co., Ltd.2016-08-30
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) (K152122)Alfa Scientific Designs, Inc.2016-06-24

Recalls involving this device

No recalls on record reference this clearance.