Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair— 510(k) K201326
Substantially EquivalentPsychemedics Corporation
FDA 510(k) clearance K201326 for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair, Substantially Equivalent on 2021-07-27. Applicant: Psychemedics Corporation. Device class: 2.
Clearance details
- Applicant
- Psychemedics Corporation
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code DJG
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view all- K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
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- K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
- K192517 — Psychemedics Microplate EIA for Cotinine in Hair
- K182103 — Psychemedics Microplate EIA for Fentanyl in Hair
Data sourced from openFDA. This site is unofficial and independent of the FDA.