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510(k) K941990

BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC by Bio-Rad — Product Code LFI

K941990 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BENOZODIAZEPINES AND TRICYLIC 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

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Other clearances for product code LFI

  • K941994 — BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC (March 20, 1995)
  • K934340 — BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESS (December 2, 1994)
  • K802245 — 7 TRICYCLIC ANTIDE PRESSANTS (October 10, 1980)

FDA data resources