FDA 510(k) Applications Submitted by KERWIN L KAUFMAN

FDA 510(k) Number Submission Date Device Name Applicant
K030213 01/21/2003 ONLINE DAT II CANNABINOIDS II ROCHE DIAGNOSTICS CORP.
K060373 02/13/2006 COBAS 6000 SERIES SYSTEM Roche Diagnostics
K021505 05/09/2002 ONLINE DAT II METHADONE II ROCHE DIAGNOSTICS CORP.
K021512 05/09/2002 COBAS INTEGRA ONLINE DAT II METHADONE II ROCHE DIAGNOSTICS CORP.
K031775 06/10/2003 PRECISET DAT PLUS I CALIBRATORS ROCHE DIAGNOSTICS CORP.
K031856 06/16/2003 PRECISET TDM I AND PRECISET TDM II CALIBRATORS ROCHE DIAGNOSTICS CORP.
K031902 06/20/2003 ONLINE TDM CARBAMAZEPINE ROCHE DIAGNOSTICS CORP.
K032279 07/24/2003 ONLINE TDM AMIKA ROCHE DIAGNOSTICS CORP.
K033165 09/30/2003 PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS ROCHE DIAGNOSTICS CORP.
K023281 10/01/2002 ONLINE DAT II COCAINE II ROCHE DIAGNOSTICS CORP.
K023296 10/02/2002 COBAS INTEGRA ONLINE DAT II COCAINE II ROCHE DIAGNOSTICS CORP.
K033246 10/07/2003 PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS ROCHE DIAGNOSTICS CORP.
K033306 10/14/2003 PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS ROCHE DIAGNOSTICS CORP.
K013482 10/19/2001 ABUSCREEN ONLINE OPIATES 300 / 2000 ROCHE DIAGNOSTICS CORP.
K053165 11/14/2005 ISE INDIRECT NA, K, CL FOR GEN.2 ROCHE DIAGNOSTICS CORP.
K043211 11/19/2004 ONLINE DAT BARBITURATES PLUS ROCHE DIAGNOSTICS CORP.
K063520 11/21/2006 ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS Roche Diagnostics
K043303 11/30/2004 ONLINE DAT PROPOXYPHENE PLUS ROCHE DIAGNOSTICS CORP.
K043327 12/02/2004 ONLINE DAT BENZODIAZEPINES PLUS ROCHE DIAGNOSTICS CORP.
K080811 03/24/2008 TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET ROCHE DIAGNOSTICS CORP.
K072638 09/18/2007 ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 ROCHE DIAGNOSTICS CORP.
K062972 09/29/2006 PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS ROCHE DIAGNOSTICS CORP.
K073277 11/21/2007 ROCHE-CREACTIVE PROTEIN (LATEX) ROCHE DIAGNOSTICS CORP.


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