Product code GMJ— Microbiology

FDA has cleared 12 devices under product code GMJ between 1976 and 1983, 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.

• 19831 clearance
• 19811 clearance
• 19805 clearances
• 19793 clearances
• 19762 clearances

• Meridian Diagnostics, Inc.4 clearances
• Immuno-Mycologics, Inc.4 clearances
• I M, Inc.2 clearances
• Nolan Biological Laboratories, Inc.1 clearance
• American Scientific Products1 clearance

• K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.·1983-05-05
• K813359 — MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLAmerican Scientific Products·1981-12-31
• K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUMNolan Biological Laboratories, Inc.·1980-09-26
• K792701 — HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.·1980-01-23
• K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.·1980-01-17
• K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASEMeridian Diagnostics, Inc.·1980-01-17
• K792711 — HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.·1980-01-17
• K791384 — FUNGAL IMMUNODIFFUSION KIT #ID1001Immuno-Mycologics, Inc.·1979-08-16
• K791393 — HISTOPLASMA YEAST ANTI #CF10021XImmuno-Mycologics, Inc.·1979-08-16
• K791394 — HISTOPLASMA MYCELIAL #CF10020XImmuno-Mycologics, Inc.·1979-08-16
• K760826 — HISTOPLASMA MYCELIAL ANTIGENI M, Inc.·1976-11-01
• K760827 — HISTOPLASMA YEAST ANTIGENI M, Inc.·1976-11-01