K210327 is an FDA 510(k) clearance for the First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup. This device is classified as a Test, Propoxyphene, Over The Counter (Class II - Special Controls, product code QBF).
Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on August 12, 2021, 189 days after receiving the submission on February 4, 2021.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700. The Propoxyphene Test Is An In Vitro Diagnostic Test For The Qualitative Detection Of Propoxyphene In Human Urine. The Test Is Intended For Over-the-counter Use As The First Step In A Two Step Process To Provide Consumers With Information Concerning The Presence Or Absence Of Propoxyphene In A Urine Sample..
| 510(k) Number | K210327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2021 |
| Decision Date | August 12, 2021 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | QBF - Test, Propoxyphene, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3700 |
| Definition | The Propoxyphene Test Is An In Vitro Diagnostic Test For The Qualitative Detection Of Propoxyphene In Human Urine. The Test Is Intended For Over-the-counter Use As The First Step In A Two Step Process To Provide Consumers With Information Concerning The Presence Or Absence Of Propoxyphene In A Urine Sample. |