FDA 510(k) Applications for Medical Device Product Code "JTO"
(Discs, Strips And Reagents, Microorganism Differentiation)

FDA 510(k) Number Applicant Device Name Decision Date
K050352 AMERITEK RESEARCH LLC IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT 09/01/2005
K954783 DIFCO LABORATORIES, INC. DRYSLIDE CARTARRHALIS 02/06/1996
K955826 GIBSON LABORATORIES, INC. GIBSON ID-M. CAT. 02/29/1996
K961191 HARDY DIAGNOSTICS COLISCREEN 06/17/1996
K960996 HARDY DIAGNOSTICS M. CAT BUTYRATE DISK 04/18/1996
K962966 INNOVATIVE DIAGNOSTIC SYSTEMS, INC. IDS RAPID CB PLUS SYSTEM 10/08/1996
K970009 MICRO BIO LOGICS, INC. LYFO(TM) DIFFERENTIAL DISK-BACITRACIN 02/06/1997
K970834 REMEL, INC. GRAM SWAB 04/17/1997
K970833 REMEL, INC. INDOLE SWAB 04/02/1997
K970832 REMEL, INC. PYR SWAB 04/24/1997


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