AT HOME DRUG TEST, MODEL 9073— 510(k) K994219

Substantially Equivalent

Phamatech

FDA 510(k) clearance K994219 for AT HOME DRUG TEST, MODEL 9073, Substantially Equivalent on 1999-12-30. Applicant: Phamatech. Device class: 2.

Clearance details

Applicant: Phamatech
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1999-12-15
Decision date: 1999-12-30
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
K211973 — DRI Cocaine Metabolite Assay2021-09-24
K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
K181499 — DRI Cocaine Metabolite Assay2018-07-06
K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

More clearances from Phamatech

K041578 — QUICKSCREEN, MODELS 9177X AND 9178X2004-09-10
K030447 — AT HOME DRUG CUP, MODEL 9150X2003-04-14
K010833 — AT WORK DRUG TEST, MODEL 9177T AWT2001-04-11
K010836 — AT WORK DRUG TEST, MODEL 9147T AWT2001-04-11
K010653 — AT HOME DRUG TEST, MODEL 9068 T2001-04-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.