Psychemedics Microplate EIA for Cotinine in Hair— 510(k) K192517
Substantially EquivalentPsychemedics Corporation
FDA 510(k) clearance K192517 for Psychemedics Microplate EIA for Cotinine in Hair, Substantially Equivalent on 2020-04-22. Applicant: Psychemedics Corporation. Device class: 1.
Clearance details
- Applicant
- Psychemedics Corporation
- Product code
- Code MKU
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code MKU
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- K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
- K182103 — Psychemedics Microplate EIA for Fentanyl in Hair
Data sourced from openFDA. This site is unofficial and independent of the FDA.