510(k) K802245
K802245 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "7 TRICYCLIC ANTIDE PRESSANTS". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code LFI (High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1980
- Date Received
- September 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- Device Class
- Class II
- Regulation Number
- 862.3910
- Review Panel
- TX
- Submission Type