Product code GMM— Microbiology

FDA has cleared 8 devices under product code GMM between 1977 and 1998, filed by 7 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.

• 19981 clearance
• 19951 clearance
• 19852 clearances
• 19831 clearance
• 19801 clearance
• 19791 clearance
• 19771 clearance

• Si Sero-Immuno Diagnostics, Inc.2 clearances
• Syn-Kit, Inc.1 clearance
• Pyramid Biological Corp.1 clearance
• Parasitic Disease Consultants1 clearance
• Instrumentation Laboratory CO1 clearance
• Calbiochem-Behring Corp.1 clearance
• Burroughs Wellcome Co.1 clearance

• K981263 — TOXOGENInstrumentation Laboratory CO·1998-08-06
• K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDIIPyramid Biological Corp.·1995-11-20
• K851976 — HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KITSi Sero-Immuno Diagnostics, Inc.·1985-10-16
• K851977 — HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KITSi Sero-Immuno Diagnostics, Inc.·1985-10-16
• K830870 — POLYCHACO INDIRECT HEMAGGLUTINATIONParasitic Disease Consultants·1983-08-12
• K802452 — TOXOTEST-MT EIKEN KITSyn-Kit, Inc.·1980-12-18
• K790460 — TXOCELL-IHA REAGENT SYSTEMCalbiochem-Behring Corp.·1979-05-25
• K771560 — TOXHA TESTBurroughs Wellcome Co.·1977-09-15