Product code JXO— Clinical Toxicology

FDA has cleared 6 devices under product code JXO between 1991 and 2021, filed by 5 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.

• 20211 clearance
• 20121 clearance
• 19923 clearances
• 19911 clearance

• Solarcare Technologies Corp,Inc.2 clearances
• Serex, Inc.1 clearance
• Psychemedics Corporation1 clearance
• Psychemedics Corp.1 clearance
• Instrumentation Laboratory CO1 clearance

• K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation·2021-06-25
• K111925 — PSYCHEMEDICS COCAINE EIAPsychemedics Corp.·2012-05-01
• K923314 — AUTOMATES COMA PLUS COCAINE METABOLITE ASSAYSerex, Inc.·1992-08-24
• K921140 — STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIASolarcare Technologies Corp,Inc.·1992-08-20
• K915785 — STC DIAGNOSTICS BENZOYLECGONINE EIASolarcare Technologies Corp,Inc.·1992-03-11
• K913737 — IL TEST(TM) COCAINEInstrumentation Laboratory CO·1991-12-03