510(k) K190397
K190397 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA". The FDA issued a decision of Substantially Equivalent on November 15, 2019. The device falls under product code QBK (Meprobamate Test System), a Class II device regulated under 21 CFR 862.3590. Immunalysis Corporation has at least 10 other 510(k) clearances on record.
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).