510(k) K014192
K014192 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET". The FDA issued a decision of Substantially Equivalent on May 23, 2002. The device falls under product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter), a Class U device. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2002
- Date Received
- December 21, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
- Device Class
- Class U
- Regulation Number
- Review Panel
- TX
- Submission Type