510(k) K992068
K992068 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "STATUS STIK, ACCUSIGN STIK". The FDA issued a decision of Substantially Equivalent on July 6, 1999. The device falls under product code DKE (Reagents, Test, Tetrahydrocannabinol), a Class II device regulated under 21 CFR 862.3870. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1999
- Date Received
- June 18, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagents, Test, Tetrahydrocannabinol
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type