Product code LFI— Clinical Toxicology

FDA has cleared 4 devices under product code LFI between 1980 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19952 clearances
• 19941 clearance
• 19801 clearance

• Bio-Rad2 clearances
• Technicon Instruments Corp.1 clearance
• Biosite Incorporated1 clearance

• K941990 — BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLCBio-Rad·1995-03-20
• K941994 — BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLCBio-Rad·1995-03-20
• K934340 — BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTSBiosite Incorporated·1994-12-02
• K802245 — 7 TRICYCLIC ANTIDE PRESSANTSTechnicon Instruments Corp.·1980-10-10