FDA 510(k) Applications for Medical Device Product Code "JCN"
(Control, Cell Counter, Normal And Abnormal)

FDA 510(k) Number Applicant Device Name Decision Date
K821956 BAKER INSTRUCTIONS CORP. HAEM-C PLUS BLOOD REFERENCE CONTROLS 07/30/1982
K942209 BIO-RAD LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH 06/16/1994
K902389 HEMATRONIX, INC. TRI-COUNT 16 08/22/1990
K895373 MEDICAL SPECIALTIES INTL., INC. HEMATOLOGY CONTROL 10/06/1989
K934497 R & D SYSTEMS, INC. CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE 12/06/1993
K874386 R & D SYSTEMS, INC. CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE 12/30/1987
K891907 R & D SYSTEMS, INC. QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED 04/11/1989
K901875 STRECK LABORATORIES, INC. PARA 12 PLUS 05/30/1990
K896154 STRECK LABORATORIES, INC. PARA TECH FOR TECHNICON H-1 11/09/1989
K993825 STRECK LABORATORIES, INC. PARA TECH PLUS RETICS 11/30/1999
K911582 STRECK LABORATORIES, INC. STAK-CHEX 05/28/1991
K902391 UNIPATH LTD. CELL-DYN 3000 CONTROL 08/22/1990


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