FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PSYCHEMEDICS PHENCYCLIDINE EIA
K Number: K111928
·
Decision May 1, 2012
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
12
Review Days
300
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Basic Information
- Device Name
- PSYCHEMEDICS PHENCYCLIDINE EIA
- K Number
- K111928
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Psychemedics Corp.
- Date Received
- July 6, 2011
- Decision Date
- May 1, 2012
- Product Code
- LCM
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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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 |
| K111926 | PSYCHEMEDICS OPIATES EIA | May 1, 2012 | Substantially Equivalent |
| K111925 | PSYCHEMEDICS COCAINE 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 |