FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
K Number: K201326
·
Decision Jul 27, 2021
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
7
Review Days
434
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Basic Information
- Device Name
- Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
- K Number
- K201326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Psychemedics Corporation
- Date Received
- May 19, 2020
- Decision Date
- July 27, 2021
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by Psychemedics Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | Apr 18, 2022 | Substantially Equivalent |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Dec 15, 2021 | Substantially Equivalent |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | Jun 25, 2021 | Substantially Equivalent |
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Apr 22, 2020 | Substantially Equivalent |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | Apr 18, 2019 | Substantially Equivalent |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | Sep 15, 2017 | Substantially Equivalent |