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510(k) K190397

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA by Immunalysis Corporation — Product Code QBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
February 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meprobamate Test System
Device Class
Class II
Regulation Number
862.3590
Review Panel
TX
Submission Type

A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).

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Other clearances for product code QBK

  • DEN170010 — LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (April 20, 2018)