First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.— 510(k) K152551
Substantially EquivalentW.H.P.M., Inc.
FDA 510(k) clearance K152551 for First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test., Substantially Equivalent on 2015-11-09. Applicant: W.H.P.M., Inc.. Device class: 2.
Clearance details
- Applicant
- W.H.P.M., Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irwindale, CA, US
Recent devices under product code DJG
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- K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
- K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.