Product code KFH— Microbiology

FDA has cleared 4 devices under product code KFH between 1976 and 1988, 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.

• 19881 clearance
• 19802 clearances
• 19761 clearance

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

• K880029 — EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001Immuno-Mycologics, Inc.·1988-02-24
• K792681 — BLASTOMYCES DERMATITIDIS POS/CONTROLMeridian Diagnostics, Inc.·1980-01-17
• K792685 — BLASTOMYCES DERMATITIDIS, ANTISERUMMeridian Diagnostics, Inc.·1980-01-17
• K760833 — ANTI-BLASTOMYCES CONTROL SERUM (YEAST)I M, Inc.·1976-11-01