Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA— 510(k) K190397

Name: FDA 510(k) clearance K190397
Creator: U.S. Food and Drug Administration
Published: 2019-11-15

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K190397 for Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA, Substantially Equivalent on 2019-11-15. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code QBK
Device class: Class 2
Regulation: 21 CFR 862.3590
Advisory panel: Clinical Toxicology
Date received: 2019-02-19
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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