Immunalysis Tapentadol Urine HEIA— 510(k) K203527

Name: FDA 510(k) clearance K203527
Creator: U.S. Food and Drug Administration
Published: 2022-05-09

Substantially Equivalent

Lmmunalysis Corporation

FDA 510(k) clearance K203527 for Immunalysis Tapentadol Urine HEIA, Substantially Equivalent on 2022-05-09. Applicant: Lmmunalysis Corporation. Device class: 2.

Clearance details

Applicant: Lmmunalysis Corporation
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2020-12-02
Decision date: 2022-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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