Product code KLR— Clinical Toxicology

FDA has cleared 17 devices under product code KLR between 1980 and 2009, filed by 11 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.

• 20091 clearance
• 20042 clearances
• 19971 clearance
• 19881 clearance
• 19851 clearance
• 19841 clearance
• 19837 clearances
• 19821 clearance
• 19802 clearances

• Syva Co.6 clearances
• E.I. Dupont DE Nemours & Co., Inc.2 clearances
• Thermo Fisher Scientific, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• Diagnostic Systems1 clearance
• Diagnostic Reagents, Inc.1 clearance
• Dade Behring, Inc.1 clearance
• American Diagnostic Corp.1 clearance
• American Dade1 clearance

• K090282 — QMS LIDOCAINEThermo Fisher Scientific, Inc.·2009-05-29
• K033809 — DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49DDade Behring, Inc.·2004-02-20
• K032334 — ROCHE ONLINE TDM LIDOCAINERoche Diagnostics Corp.·2004-01-12
• K973102 — LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.·1997-09-12
• K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic Systems·1988-06-20
• K853010 — COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, Inc.·1985-08-07
• K843184 — STRATUS LIDOCAINE FLUOROMETRIC ENZYMEAmerican Dade·1984-09-26
• K833379 — LIDOCAINE ANALYTICAL TEST PACK ACAE.I. Dupont DE Nemours & Co., Inc.·1983-12-27
• K833381 — VALPROIC ACID ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1983-12-27
• K833623 — MODIF. OF EMIT CAD DISOPYRAMIDE ASSAYSyva Co.·1983-12-08
• K832799 — MODIFICA- OF EMIT CAD LIDOCAINE ASSAYSyva Co.·1983-10-14
• K831354 — EMIT QST LIDOCAINE ASSAYSyva Co.·1983-05-27
• K823887 — ADVANCE EMIT CAD DISOPYRAMIDE ASSAYSyva Co.·1983-01-28
• K823866 — ADVANCE EMIT CAD LIDOCAINE ASSAYSyva Co.·1983-01-12
• K822347 — LIDOCAINE FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.·1982-08-25
• K802131 — CYBREX LIDOCAINEAbbott Laboratories·1980-10-31
• K801204 — EMIT DISOPYRAMIDE ASSAYSyva Co.·1980-06-09