FDA 510(k) Applications Submitted by OTSUKA PHARMACEUTICAL CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K092817 09/14/2009 POC-AS10 AUTO SAMPLER OTSUKA PHARMACEUTICAL CO., LTD.
K052716 09/29/2005 RAPIRUN H. PYLORI ANTIBODY DETECTION KIT OTSUKA PHARMACEUTICAL CO., LTD.
K013371 10/11/2001 UBIT-IR300 INFRARED SPECTROMETRY SYSTEM OTSUKA PHARMACEUTICAL CO., LTD.
K041148 05/03/2004 POCONE INFRARED SPECTROPHOTOMETER OTSUKA PHARMACEUTICAL CO., LTD.
K001032 03/30/2000 RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY OTSUKA PHARMACEUTICAL CO., LTD.
K991083 03/31/1999 RLP CHOLESTEROL IMMUNOSEPARATION ASSAY OTSUKA PHARMACEUTICAL CO., LTD.


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