510(k) K062565
K062565 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE". The FDA issued a decision of Substantially Equivalent on February 20, 2007. The device falls under product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites), a Class I device regulated under 21 CFR 862.3220. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2007
- Date Received
- August 31, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Device Class
- Class I
- Regulation Number
- 862.3220
- Review Panel
- TX
- Submission Type