URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)— 510(k) K913863

Name: FDA 510(k) clearance K913863
Creator: U.S. Food and Drug Administration
Published: 1991-09-19

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K913863 for URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125), Substantially Equivalent on 1991-09-19. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1991-08-27
Decision date: 1991-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

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