Product code GMT— Microbiology

FDA has cleared 9 devices under product code GMT between 1976 and 1997, filed by 8 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.

• 19971 clearance
• 19913 clearances
• 19901 clearance
• 19891 clearance
• 19792 clearances
• 19761 clearance

• Olympus Corp.2 clearances
• Volu Sol Medical Industries1 clearance
• Scimedx Tekfile Services1 clearance
• Gamma Biologicals, Inc.1 clearance
• Fujirebio Diagnostics,Inc.1 clearance
• Fujirebio America, Inc.1 clearance
• Difco Laboratories, Inc.1 clearance
• Behring Diagnostics, Inc.1 clearance

• K971502 — SERODIA TP-PAScimedx Tekfile Services·1997-11-13
• K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.·1991-07-24
• K911266 — MODIFIED PK TP CONTROLOlympus Corp.·1991-05-07
• K905038 — OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.·1991-05-06
• K896410 — CELLOGNOST SYPHILIS HBehring Diagnostics, Inc.·1990-05-15
• K893124 — OLYMPUS PK(TM) TPFujirebio Diagnostics,Inc.·1989-11-17
• K791897 — BACTO-HATTSDifco Laboratories, Inc.·1979-11-13
• K791457 — AGGLUTINOTEST-SYPHILISVolu Sol Medical Industries·1979-09-24
• K760098 — REAGENT, VDRLGamma Biologicals, Inc.·1976-08-03