510(k) K983147
K983147 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P". The FDA issued a decision of Substantially Equivalent on September 28, 1998. 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
- September 28, 1998
- Date Received
- September 8, 1998
- Clearance Type
- Traditional
- 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