First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
FDA 510(k) clearance K160793 · decided 2016-08-17
Clearance details
- K-number
- K160793
- Device name
- First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
- Applicant
- W.H.P.M., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-23
- Decision date
- 2016-08-17
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Irwindale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.