Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair— 510(k) K201228
Substantially EquivalentPsychemedics Corporation
FDA 510(k) clearance K201228 for Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair, Substantially Equivalent on 2021-06-25. Applicant: Psychemedics Corporation. Device class: 2.
Clearance details
- Applicant
- Psychemedics Corporation
- Product code
- Code JXO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code JXO
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Data sourced from openFDA. This site is unofficial and independent of the FDA.