K190397 is an FDA 510(k) clearance for the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA. This device is classified as a Meprobamate Test System (Class II - Special Controls, product code QBK).
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on November 15, 2019, 269 days after receiving the submission on February 19, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3590. 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)..
| 510(k) Number | K190397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | QBK — Meprobamate Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3590 |
| Definition | 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). |