Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
FDA 510(k) K190397 · Immunalysis Corporation
510(k) numberK190397
Submission
- Device name
- Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
- Applicant
- Immunalysis Corporation
Pomona, CA, US - Received
- February 19, 2019
- Decision date
- November 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBK – Meprobamate Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3590
- Specialty
- Clinical Toxicology
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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Questions and answers
When was Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA cleared by the FDA?
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (K190397) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 269 days after the submission was received.
What is the product code of K190397?
The FDA product code is QBK – Meprobamate Test System, a Class II (moderate risk) device regulated under 21 CFR 862.3590.