Atlas FDA

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k) clearance K161044 · decided 2016-07-06

Clearance details

K-number
K161044
Device name
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Applicant
Assure Tech. (Hangzhou) Co, Ltd.
Decision
Substantially Equivalent
Date received
2016-04-13
Decision date
2016-07-06
Days to decision
84 days
Clearance type
Traditional
Product code
DJC
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Hangzhou, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.