LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
FDA 510(k) clearance K023837 · decided 2003-09-15
Clearance details
- K-number
- K023837
- Device name
- LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-18
- Decision date
- 2003-09-15
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- LAF
- Device class
- 2
- Regulation number
- 862.3610
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.