Submission Details
| 510(k) Number | K182103 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 2018 |
| Decision Date | April 18, 2019 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Psychemedics Microplate EIA for Fentanyl in Hair
Apr 2019
Decision
258d
Days
Class 2
Risk
About This 510(k) Submission
K182103 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Fentanyl in Hair, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on April 18, 2019, 258 days after receiving the submission on August 3, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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