Submission Details
| 510(k) Number | K212952 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 2021 |
| Decision Date | April 18, 2022 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
Apr 2022
Decision
214d
Days
—
Risk
About This 510(k) Submission
K212952 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair, a Enzyme Immunoassay, Phencyclidine, submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on April 18, 2022, 214 days after receiving the submission on September 16, 2021. This device falls under the Toxicology review panel.
Device Classification
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |
Manufacturer
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