Product code GMG— Microbiology

FDA has cleared 5 devices under product code GMG between 1976 and 1981, filed by 4 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.

• 19811 clearance
• 19801 clearance
• 19792 clearances
• 19761 clearance

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

• K812189 — COCCIDIOIDES LATEX AGGLUTINATIONAmerican Scientific Products·1981-08-25
• K792690 — COCCIDIOIDES IMMITIS, LATEX AGGLUTIMeridian Diagnostics, Inc.·1980-01-17
• K791381 — COCCIDIODES (COCCI)Immuno-Mycologics, Inc.·1979-08-16
• K782070 — REAGENT, COCCI LATEXI M, Inc.·1979-02-01
• K760829 — COCCIDIOIDES MYCELIAL ANTIGENI M, Inc.·1976-11-01