Product code GMI— Microbiology

FDA has cleared 11 devices under product code GMI between 1978 and 1989, 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.

• 19891 clearance
• 19812 clearances
• 19805 clearances
• 19792 clearances
• 19781 clearance

• Meridian Diagnostics, Inc.4 clearances
• Immuno-Mycologics, Inc.2 clearances
• American Scientific Products2 clearances
• Schiff & Co.1 clearance
• Nolan Biological Laboratories, Inc.1 clearance
• I M, Inc.1 clearance

• K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROLSchiff & Co.·1989-10-31
• K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEMAmerican Scientific Products·1981-08-31
• K812185 — FUNGAL IMMUNODIFFUSION SYSTEMAmerican Scientific Products·1981-08-25
• K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.·1980-09-26
• K792716 — CANDIDA ALBICANS, ANTIGENMeridian Diagnostics, Inc.·1980-01-24
• K792713 — CANDIDA ALBICANS, ANTISERUMMeridian Diagnostics, Inc.·1980-01-23
• K792682 — COCCIDIOIDES IMMITIS, ANTIGENMeridian Diagnostics, Inc.·1980-01-17
• K792689 — COCCIDIOIDES IMMITIS, ANTIGENMeridian Diagnostics, Inc.·1980-01-17
• K791383 — CANDIDA IMMUNODIFFUSION KIT #CA1001Immuno-Mycologics, Inc.·1979-08-16
• K791389 — COCCIDIOIDES ANTIGEN #CF10023XImmuno-Mycologics, Inc.·1979-08-16
• K770527 — CANDIDA IMMUNODIFFUSION KITI M, Inc.·1978-03-17