Atlas FDA

Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

FDA 510(k) clearance K232732 · decided 2024-01-17

Clearance details

K-number
K232732
Device name
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
Applicant
Co-Innovation Biotech Co., Ltd.
Decision
Substantially Equivalent
Date received
2023-09-07
Decision date
2024-01-17
Days to decision
132 days
Clearance type
Traditional
Product code
LDJ
Device class
2
Regulation number
862.3870
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Guangzhou, CN
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) (K232604)Hangzhou Laihe Biotech Co., Ltd.2024-01-10
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162)Healgen Scientific,, LLC2023-03-17
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (K192515)Shenzhen Bioeasy Biotechnology Co., Ltd.2019-10-11
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (K153741)Hangzhou Clongene Biotech Co., Ltd.2016-03-18
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana (K152643)Nantong Egens Biotech Co., Ltd.2015-11-02
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (K151203)Immunalysis Corporation2015-06-05
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (K141320)Lin-Zhi International, Inc.2015-05-28
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K142408)Polymed Therapeutics, Inc.2014-09-25
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (K140546)Healgen Scientific,, LLC2014-06-06
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE (K130213)Lumiquick Diagnostics, Inc.2013-10-18
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR (K132096)Biophor Diagnostics, Inc.2013-10-18
TOXCUP DRUG SCREEN CUP (K122633)Branan Medical Corp.2013-02-07

Recalls involving this device

No recalls on record reference this clearance.