510(k) K941994
K941994 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC". The FDA issued a decision of Substantially Equivalent on March 20, 1995. The device falls under product code LFI (High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Bio-Rad has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 1995
- Date Received
- April 25, 1994
- 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