Product code LFT— Clinical Toxicology

FDA has cleared 8 devices under product code LFT between 1981 and 1995, filed by 8 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.

• 19951 clearance
• 19901 clearance
• 19891 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19821 clearance
• 19811 clearance

• Tudor Laboratories, Inc.1 clearance
• Syva Co.1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Baxter Healthcare Corp1 clearance
• American Diagnostic Corp.1 clearance
• American Dade1 clearance

• K950028 — PRIMIDONE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.·1995-03-21
• K904683 — STRATUS PRIMIDONE FLUOROMETRIC ENZYMEBaxter Healthcare Corp·1990-11-28
• K895567 — PRIMIDONE (FPIA) KITTudor Laboratories, Inc.·1989-10-20
• K852318 — COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORSRoche Diagnostic Systems, Inc.·1985-06-25
• K842196 — STRATUS PRIMIDONE FLOROMETRIC ENZYAmerican Dade·1984-07-11
• K823741 — ADVANCE EMIT-AED PRIMEDONE ASSAYSyva Co.·1983-01-07
• K822229 — PRIMIDONE FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.·1982-08-12
• K811007 — AMES TDA TM PRIMIDONE TESTMiles Laboratories, Inc.·1981-04-29