ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)— 510(k) K040327

Name: FDA 510(k) clearance K040327
Creator: U.S. Food and Drug Administration
Published: 2004-04-19

Substantially Equivalent

Accu-Stat Diagnostics, Inc.

FDA 510(k) clearance K040327 for ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC), Substantially Equivalent on 2004-04-19. Applicant: Accu-Stat Diagnostics, Inc.. Device class: Unclassified.

Clearance details

Applicant: Accu-Stat Diagnostics, Inc.
Product code: Code MVO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2004-02-10
Decision date: 2004-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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K013409 — AT HOME DRUG TEST, MODEL 90742001-12-06
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