PSYCHEMEDICS PHENCYCLIDINE EIA
FDA 510(k) clearance K111928 · decided 2012-05-01
Clearance details
- K-number
- K111928
- Device name
- PSYCHEMEDICS PHENCYCLIDINE EIA
- Applicant
- Psychemedics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-06
- Decision date
- 2012-05-01
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.