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)— 510(k) K161044
Substantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.
FDA 510(k) clearance K161044 for 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), Substantially Equivalent on 2016-07-06. Applicant: Assure Tech. (Hangzhou) Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
- Product code
- Code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code DJC
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- K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
- K181305 — OralTox Oral fluid Drug Test
- K171403 — OralTox Oral Fluid Drug Test
More clearances from Assure Tech. (Hangzhou) Co, Ltd.
view all- K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
- K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
- K181768 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K180349 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.