FDA 510(k) Applications Submitted by Patricia Klimley

FDA 510(k) Number Submission Date Device Name Applicant
K092587 08/24/2009 BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM Bio-Rad Laboratories
K973674 09/26/1997 ELECSYS FOLATE BOEHRINGER MANNHEIM CORP.
K970452 02/06/1997 ELECSYS CALCHECK CEA BOEHRINGER MANNHEIM CORP.
K970458 02/06/1997 ELECSYS CALCHECK PSA BOEHRINGER MANNHEIM CORP.
K970459 02/06/1997 ELECSYS CALCHECK CEA BOEHRINGER MANNHEIM CORP.
K980887 03/09/1998 ELECSYS CEA ON THE ELECSYS 1010 BOEHRINGER MANNHEIM CORP.
K981278 04/08/1998 ELECSYS CALCHECK CA 125II ROCHE DIAGNOSTICS GMBH
K981282 04/08/1998 ELECSYS AFP ROCHE DIAGNOSTICS GMBH
K981931 06/02/1998 CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH
K973351 09/05/1997 ELECSYS AFP BOEHRINGER MANNHEIM CORP.
K993107 09/17/1999 BIO-RAD HOMOCYSTEINE BY HPLC BIO-RAD
K974189 11/07/1997 ELECSYS PSA (ON ELECSYS 1010) BOEHRINGER MANNHEIM CORP.
K974383 11/21/1997 ELECSYS CALCHECK VITAMIN B12 BOEHRINGER MANNHEIM CORP.
K974384 11/21/1997 ELECSYS CALCHECK FOLATE BOEHRINGER MANNHEIM CORP.


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