Product code JGM— Clinical Chemistry

FDA has cleared 5 devices under product code JGM between 1977 and 1989, 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.

• 19891 clearance
• 19861 clearance
• 19831 clearance
• 19811 clearance
• 19771 clearance

• Medical Specialties, Inc.1 clearance
• Mallinckrodt Critical Care1 clearance
• Environmental Chemical Specialties1 clearance
• Data Medical Associates, Inc.1 clearance
• Amresco, Inc.1 clearance

• K895718 — LITHIUM CONCENTRATE FOR A FLAME PHOTOMETERData Medical Associates, Inc.·1989-10-19
• K862300 — AMRESCO FLOW PAC SODIUM POTASSIUM REAGENTAmresco, Inc.·1986-07-29
• K831300 — MSI-NAK-50 TEST KITMedical Specialties, Inc.·1983-07-18
• K810253 — SODIUM & POTASSIUM TEST KITMallinckrodt Critical Care·1981-02-10
• K771068 — TRIGLYCERIDE KITEnvironmental Chemical Specialties·1977-07-12