STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
FDA 510(k) clearance K062565 · decided 2007-02-20
Clearance details
- K-number
- K062565
- Device name
- STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-31
- Decision date
- 2007-02-20
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- MKU
- Device class
- 1
- Regulation number
- 862.3220
- 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.