IMMULITE COCAINE METABOLITE— 510(k) K963918

Name: FDA 510(k) clearance K963918
Creator: U.S. Food and Drug Administration
Published: 1997-04-08

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K963918 for IMMULITE COCAINE METABOLITE, Substantially Equivalent on 1997-04-08. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1996-09-30
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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