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GMI — Antigen, Cf And / Or Id, Coccidioides Immitis Class II

FDA Device Classification

Classification Details

Product Code
GMI
Device Class
Class II
Regulation Number
866.3135
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K894617schiff andOLYMPUS PK-TP SYSTEM REACTIVE CONTROLOctober 31, 1989
K812190american scientific productsCOCCIDIOIDES IMMUNODIFFUSION SYSTEMAugust 31, 1981
K812185american scientific productsFUNGAL IMMUNODIFFUSION SYSTEMAugust 25, 1981
K802129nolan biological laboratoriesIMMUNODIFFUSION REAGENTS/SEROLOGICALSeptember 26, 1980
K792716meridian diagnosticsCANDIDA ALBICANS, ANTIGENJanuary 24, 1980
K792713meridian diagnosticsCANDIDA ALBICANS, ANTISERUMJanuary 23, 1980
K792689meridian diagnosticsCOCCIDIOIDES IMMITIS, ANTIGENJanuary 17, 1980
K792682meridian diagnosticsCOCCIDIOIDES IMMITIS, ANTIGENJanuary 17, 1980
K791383immuno-mycologicsCANDIDA IMMUNODIFFUSION KIT #CA1001August 16, 1979
K791389immuno-mycologicsCOCCIDIOIDES ANTIGEN #CF10023XAugust 16, 1979
K770527i mCANDIDA IMMUNODIFFUSION KITMarch 17, 1978