RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]— 510(k) K871549

Name: FDA 510(k) clearance K871549
Creator: U.S. Food and Drug Administration
Published: 1987-06-16

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K871549 for RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125], Substantially Equivalent on 1987-06-16. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code KLN
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1987-04-14
Decision date: 1987-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

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