Product code KLQ— Clinical Toxicology

FDA has cleared 20 devices under product code KLQ between 1978 and 2005, filed by 18 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.

• 20051 clearance
• 20041 clearance
• 19961 clearance
• 19901 clearance
• 19891 clearance
• 19851 clearance
• 19843 clearances
• 19831 clearance
• 19824 clearances
• 19811 clearance
• 19804 clearances
• 19781 clearance

• Miles Laboratories, Inc.2 clearances
• Diagnostic Products Corp.2 clearances
• Syva Co.1 clearance
• Seradyn, Inc.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• Randox Laboratories, Ltd.1 clearance
• Paragon Diagnostics, Inc.1 clearance
• P-L Biochemicals, Inc.1 clearance
• Oxis Intl., Inc.1 clearance
• Innotron of Oregon, Inc.1 clearance

• K052815 — QMS AMIKACIN REAGENTSSeradyn, Inc.·2005-11-01
• K033884 — RANDOX AMIKACINRandox Laboratories, Ltd.·2004-06-09
• K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.·1996-02-09
• K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.·1990-08-09
• K894517 — FPR AMIKACIN KITColony Laboratories, Inc.·1989-09-28
• K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic Systems, Inc.·1985-06-25
• K843211 — AMIKACIN ANALYTICAL TEST PACK ACAE.I. Dupont DE Nemours & Co., Inc.·1984-09-12
• K841161 — IMMPULSE AMIKACIN ASSAY REAGENTSParagon Diagnostics, Inc.·1984-05-02
• K840193 — EMIT QST AMIKACIN ASSAYSyva Co.·1984-03-23
• K832336 — STRATUS AMIKACIN FLUOROMETRICAmerican Dade·1983-08-31
• K822657 — EMIT-AMD AMIKACIN ASSAYDade Behring, Inc.·1982-09-28
• K821771 — MACRO-VUE CARD TEST, AMIKACINBd Becton Dickinson Vacutainer Systems Preanalytic·1982-06-25
• K820781 — COAT-A-COUNT AMIKACIN IRADiagnostic Products Corp.·1982-04-09
• K813541 — AMIKACIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.·1982-01-12
• K811026 — AMES TDA TM AMIKACIN TESTMiles Laboratories, Inc.·1981-04-29
• K802877 — AMIKACIN RIA KITAntibodies, Inc.·1980-12-19
• K802669 — CYBREX AMIKACINAbbott Laboratories·1980-11-12
• K801130 — AMES TDA AMIKACINMiles Laboratories, Inc.·1980-05-28
• K800517 — TOBRAM E.R.A. TMP-L Biochemicals, Inc.·1980-03-20
• K780494 — AMIKACINDiagnostic Products Corp.·1978-04-10