Product code GMH— Microbiology

FDA has cleared 5 devices under product code GMH between 1976 and 1980, filed by 3 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.

• 19803 clearances
• 19791 clearance
• 19761 clearance

• Meridian Diagnostics, Inc.3 clearances
• Immuno-Mycologics, Inc.1 clearance
• I M, Inc.1 clearance

• K792684 — COCCIDIOIDES IMMITIS, ANTISERUM,Meridian Diagnostics, Inc.·1980-01-17
• K792688 — COCCIDIOIDES IMMITIS, ANTISERUMMeridian Diagnostics, Inc.·1980-01-17
• K792717 — COCCIDIOIDES IMMITIS, ANTISERUM POS.Meridian Diagnostics, Inc.·1980-01-17
• K791388 — ANTI-COCCIDIOIDES SERUM #CF10028XImmuno-Mycologics, Inc.·1979-08-16
• K760834 — ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)I M, Inc.·1976-11-01