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JSX — Kit, Identification, Neisseria Gonorrhoeae Class I

FDA Device Classification

Classification Details

Product Code
JSX
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K960759medtex laboratoriesGONOPOX TEST KITSeptember 18, 1996
K923566remelNIZYME TEST KITNovember 2, 1992
K913456kev connecticut diagnosticsVISI-NEISSERIAOctober 11, 1991
K880511austin biological laboratoriesXACT NEISSERIAAugust 25, 1988
K881501innovative diagnostic systemsMODIFIED IDS RAPID NH SYSTEMMay 18, 1988
K870117pro-labNEISSERIA/BRANHAMELLA DIFFERENTIAL TESTMarch 20, 1987
K853544analytical productsQUAD FERM +September 5, 1985
K852998micro-bio-logicsNEISSERIA - KWIK PLUSJuly 23, 1985
K852582culture kitsGONI-KITJuly 12, 1985
K833307pharmaciaPHADEBACK G.C. POSITIVE CONTROLSDecember 27, 1983
K833180e-y laboratoriesGONOCHEK-IINovember 14, 1983
K830364oxoid u.s.aNEISSERIA IDENTIFICATION DISCSMarch 8, 1983
K812048carr-scarborough microbiologicalsIDS RAPIDS NH SYSTEMSAugust 18, 1981
K811412windsor laboratoriesNEISSERIA-KWIKJune 16, 1981
K782013abbott laboratoriesGONO-CELLApril 23, 1979
K781108miles laboratoriesMICROCULT-GC CULTURE TESTAugust 31, 1978