510(k) K990786
K990786 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/". The FDA issued a decision of Substantially Equivalent on March 26, 1999. The device falls under product code LAG (High Pressure Liquid Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1999
- Date Received
- March 10, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Pressure Liquid Chromatography, Methamphetamine
- Device Class
- Class II
- Regulation Number
- 862.3610
- Review Panel
- TX
- Submission Type