FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PSYCHEMEDICS COCAINE EIA
K Number: K111925
·
Decision May 1, 2012
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
5
Applicant Total
12
Review Days
300
Basic Information
- Device Name
- PSYCHEMEDICS COCAINE EIA
- K Number
- K111925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PSYCHEMEDICS CORP.
- Date Received
- July 6, 2011
- Decision Date
- May 1, 2012
- Product Code
- JXO
- 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 |
|---|---|---|---|
| JXO | Enzyme Immunoassay, Cocaine | FDA class 2 | Clinical Toxicology |
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Other Clearances by PSYCHEMEDICS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K130811 | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE | May 2, 2013 | Substantially Equivalent |
| K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR | Feb 8, 2013 | Substantially Equivalent |
| K111927 | PSYCHEMEDICS METHAMPHETAMINE EIA | May 1, 2012 | Substantially Equivalent |
| K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA | May 1, 2012 | Substantially Equivalent |
| K111926 | PSYCHEMEDICS OPIATES EIA | May 1, 2012 | Substantially Equivalent |
| K111929 | PSYCHEMEDICS CANNABINOIDS EIA | May 1, 2012 | Substantially Equivalent |
| K011426 | PSYCHEMEDICS RIA CANNABINOID ASSAY | May 3, 2002 | Substantially Equivalent |
| K011275 | PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY | Feb 11, 2002 | Substantially Equivalent |
| K011185 | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY | Jan 24, 2002 | Substantially Equivalent |
| K010868 | PSYCHEMEDICS RIA COCAINE ASSAY | Nov 6, 2001 | Substantially Equivalent |