Product code LFN— Clinical Toxicology

FDA has cleared 5 devices under product code LFN between 1982 and 1994, filed by 4 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.

• 19941 clearance
• 19871 clearance
• 19862 clearances
• 19821 clearance

• E.I. Dupont DE Nemours & Co., Inc.2 clearances
• Seradyn, Inc.1 clearance
• Electro-Nucleonics Laboratories, Inc.1 clearance
• Coulter Electronics, Inc.1 clearance

• K934388 — QMS PHENOBARBITALSeradyn, Inc.·1994-02-25
• K864612 — DART PHENOBARBITAL ASSAY SYSTEMCoulter Electronics, Inc.·1987-01-13
• K860303 — DUPONT PHENOBARBITAL CALIBRATORE.I. Dupont DE Nemours & Co., Inc.·1986-02-28
• K860304 — DUPONT PHENOBARBITAL ASSAYE.I. Dupont DE Nemours & Co., Inc.·1986-02-28
• K821543 — IPA FOR DETECTION OF PHENOBARBITALElectro-Nucleonics Laboratories, Inc.·1982-06-03