FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Psychemedics Microplate EIA for Benzodiazepines in Hair
K Number: K163590
·
Decision Sep 15, 2017
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
7
Review Days
269
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Basic Information
- Device Name
- Psychemedics Microplate EIA for Benzodiazepines in Hair
- K Number
- K163590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Psychemedics Corporation
- Date Received
- December 20, 2016
- Decision Date
- September 15, 2017
- Product Code
- JXM
- 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 |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | 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 |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | Jul 27, 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 |