LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay— 510(k) DEN170010

Name: FDA 510(k) clearance DEN170010
Creator: U.S. Food and Drug Administration
Published: 2018-04-20

Unknown

Lin-Zhi International, Inc.

FDA 510(k) clearance DEN170010 for LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay, Unknown on 2018-04-20. Applicant: Lin-Zhi International, Inc.. Device class: 2.

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code QBK
Device class: Class 2
Regulation: 21 CFR 862.3590
Advisory panel: Clinical Toxicology
Date received: 2017-02-21
Decision date: 2018-04-20
Decision: Unknown
Clearance type: Direct
Location: Santa Clara, CA, US

View on FDA.gov ↗

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