Submission Details
| 510(k) Number | K192517 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 2019 |
| Decision Date | April 22, 2020 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Psychemedics Microplate EIA for Cotinine in Hair
Apr 2020
Decision
222d
Days
Class 1
Risk
About This 510(k) Submission
K192517 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Cotinine in Hair, a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I — General Controls, product code MKU), submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on April 22, 2020, 222 days after receiving the submission on September 13, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3220.
Device Classification
| Product Code | MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.3220 |
Manufacturer
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