FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K Number: K130811
·
Decision May 2, 2013
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
12
Review Days
38
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Basic Information
- Device Name
- PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
- K Number
- K130811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Psychemedics Corp.
- Date Received
- March 25, 2013
- Decision Date
- May 2, 2013
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Psychemedics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR | Feb 8, 2013 | Substantially Equivalent |
| K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA | May 1, 2012 | 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 |