Product code LCS— Clinical Toxicology

FDA has cleared 15 devices under product code LCS between 1977 and 1992, filed by 15 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.

• 19921 clearance
• 19911 clearance
• 19892 clearances
• 19881 clearance
• 19871 clearance
• 19821 clearance
• 19811 clearance
• 19806 clearances
• 19771 clearance

• Technia Diagnostics , Ltd.1 clearance
• Sorin Biomedica, Fiat, USA, Inc.1 clearance
• Seradyn, Inc.1 clearance
• Sclavo, Inc.1 clearance
• Pharmacia, Inc.1 clearance
• Pcl-Ria, Inc.1 clearance
• Monobind1 clearance
• M.A. Bioproducts1 clearance
• Innotron of Oregon, Inc.1 clearance
• E. R. Squibb & Sons, Inc.1 clearance

• K922353 — DIGOXIN COATED TUBE RIAMonobind·1992-08-24
• K913562 — QMS - DIGOXINSeradyn, Inc.·1991-08-30
• K895828 — INNOFLUOR DIGOXIN REAGENT SETInnotron of Oregon, Inc.·1989-10-30
• K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.·1989-01-17
• K874748 — IMMPULSE DIGOXIN ASSAY REAGENTSSclavo, Inc.·1988-02-19
• K864802 — DART DIGOXIN ASSAYCoulter Electronics, Inc.·1987-02-12
• K820154 — TDX DIGOXINAbbott Laboratories·1982-02-05
• K812749 — ULTRA-DIGAntibodies, Inc.·1981-10-19
• K803047 — I-125 LABELED DIGOXINPcl-Ria, Inc.·1980-12-22
• K801490 — DIGOXIN EIA KITM.A. Bioproducts·1980-07-14
• K801413 — AMERLEX DIGOXIN RIA KITAmersham Corp.·1980-07-08
• K801202 — DIGOXIN RADIOIMMUNOASSAY KITTechnia Diagnostics , Ltd.·1980-06-20
• K800997 — DIGOXIN CLASP RIA KITE. R. Squibb & Sons, Inc.·1980-05-08
• K800773 — DIGOCTK 125Sorin Biomedica, Fiat, USA, Inc.·1980-04-24
• K770322 — PHALDEBAS DIGOXIN RIAPharmacia, Inc.·1977-04-05