Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
FDA 510(k) clearance K201228 · decided 2021-06-25
Clearance details
- K-number
- K201228
- Device name
- Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
- Applicant
- Psychemedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-05-07
- Decision date
- 2021-06-25
- Days to decision
- 414 days
- Clearance type
- Traditional
- Product code
- JXO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PSYCHEMEDICS COCAINE EIA (K111925) | Psychemedics Corp. | 2012-05-01 |
| AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (K923314) | Serex, Inc. | 1992-08-24 |
| STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (K921140) | Solarcare Technologies Corp,Inc. | 1992-08-20 |
| STC DIAGNOSTICS BENZOYLECGONINE EIA (K915785) | Solarcare Technologies Corp,Inc. | 1992-03-11 |
| IL TEST(TM) COCAINE (K913737) | Instrumentation Laboratory CO | 1991-12-03 |
Recalls involving this device
No recalls on record reference this clearance.