QUICK SCREEN ONE STEP AMPHETAMINE TEST— 510(k) K972577

Name: FDA 510(k) clearance K972577
Creator: U.S. Food and Drug Administration
Published: 1997-08-20

Substantially Equivalent

Phamatech

FDA 510(k) clearance K972577 for QUICK SCREEN ONE STEP AMPHETAMINE TEST, Substantially Equivalent on 1997-08-20. Applicant: Phamatech. Device class: 2.

Clearance details

Applicant: Phamatech
Product code: Code DIT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1997-07-10
Decision date: 1997-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIT

view all

K910525 — MICROLINE SCREEN FOR METHAMPHETAMINE1991-04-05
K901276 — HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL1990-04-26
K790805 — DRUG ABUSE DIPSTICKS1979-06-06

More clearances from Phamatech

view all

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.