ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE— 510(k) K040445

Name: FDA 510(k) clearance K040445
Creator: U.S. Food and Drug Administration
Published: 2004-05-19

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K040445 for ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE, Substantially Equivalent on 2004-05-19. Applicant: ACON Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code JXN
Device class: Class 2
Regulation: 21 CFR 862.3700
Advisory panel: Clinical Toxicology
Date received: 2004-02-20
Decision date: 2004-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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