Product code KJI— Clinical Toxicology

FDA has cleared 6 devices under product code KJI between 1978 and 1983, filed by 6 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.

• 19831 clearance
• 19823 clearances
• 19791 clearance
• 19781 clearance

• Syva Co.1 clearance
• Monitor Science Corp.1 clearance
• Miles Laboratories, Inc.1 clearance
• Diagnostic Products Corp.1 clearance
• American Diagnostic Corp.1 clearance
• Abbott Laboratories1 clearance

• K832769 — AMES TDA KANAMYCIN TEST-CONTROL SERUMMiles Laboratories, Inc.·1983-09-29
• K823370 — ADVANCE TM EMIT(R) & TM AMIKACIN ASSAYSyva Co.·1982-12-03
• K823062 — KENAMYCIN FLUORESCENT IMMUNOASSAY FIAAmerican Diagnostic Corp.·1982-11-10
• K822808 — TDX KENAMYCINAbbott Laboratories·1982-10-08
• K782125 — RIA KIT, KANAMYCINDiagnostic Products Corp.·1979-01-10
• K772038 — KANAMYCIN RIAMonitor Science Corp.·1978-01-12