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GMJ — Antigens, Histoplasma Capsulatum, All Class II

FDA Device Classification

Classification Details

Product Code
GMJ
Device Class
Class II
Regulation Number
866.3320
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K830837immuno-mycologicsLA-HISTO ANTIBODY SYSTEM #HL 1001May 5, 1983
K813359american scientific productsMYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLDecember 31, 1981
K802130nolan biological laboratoriesIMMUNO. IDENTIFICATION OF H. CAPSULATUMSeptember 26, 1980
K792701meridian diagnosticsHISTOPLASMA CAPSULATUM, ANTIGENJanuary 23, 1980
K792708meridian diagnosticsHISTOPLASMA CAPSULATUM, MYCELIAL PHASEJanuary 17, 1980
K792704meridian diagnosticsHISTOPLASMA CAPSULATUM, ANTIGEN YEASTJanuary 17, 1980
K792711meridian diagnosticsHISTOPLASMA CAPSULATUM, ANTISERUMJanuary 17, 1980
K791384immuno-mycologicsFUNGAL IMMUNODIFFUSION KIT #ID1001August 16, 1979
K791393immuno-mycologicsHISTOPLASMA YEAST ANTI #CF10021XAugust 16, 1979
K791394immuno-mycologicsHISTOPLASMA MYCELIAL #CF10020XAugust 16, 1979
K760827i mHISTOPLASMA YEAST ANTIGENNovember 1, 1976
K760826i mHISTOPLASMA MYCELIAL ANTIGENNovember 1, 1976