ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE— 510(k) K040629

Substantially Equivalent

Accu-Stat Diagnostics, Inc.

FDA 510(k) clearance K040629 for ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE, Substantially Equivalent on 2004-05-05. Applicant: Accu-Stat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Accu-Stat Diagnostics, Inc.
Product code
Code LDJ
Device class
Class 2
Regulation
21 CFR 862.3870
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Forest, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LDJ

view all

More clearances from Accu-Stat Diagnostics, Inc.

view all

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