FDA 510(k) Applications Submitted by JENNIFER L TRIBBETT

FDA 510(k) Number Submission Date Device Name Applicant
K000096 01/13/2000 ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 ROCHE DIAGNOSTICS CORP.
K040174 01/26/2004 BILIRUBIN ASSAY ON THE OMNI S ANALYZER ROCHE DIAGNOSTICS CORP.
K990377 02/08/1999 ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV ROCHE DIAGNOSTICS CORP.
K990399 02/09/1999 ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 ROCHE DIAGNOSTICS CORP.
K020831 03/14/2002 PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 ROCHE DIAGNOSTICS CORP.
K030845 03/17/2003 COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING ROCHE DIAGNOSTICS CORP.
K060978 04/10/2006 COAGUCHEK XS SYSTEM Roche Diagnostics
K021190 04/15/2002 PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 ROCHE DIAGNOSTICS CORP.
K111119 04/21/2011 TRABECULAR METAL (TM) FUSION DEVICE ZIMMER SPINE, INC
K001356 04/28/2000 ONTRAK TESTCUP PRO-5, MODEL 1986678 ROCHE DIAGNOSTICS CORP.
K081193 04/28/2008 COBAS INTEGRA 400/800 BILIRUBIN TOTAL Roche Diagnostics
K001417 05/05/2000 ONTRAK TESTCUP 502, MODEL 3016641 ROCHE DIAGNOSTICS CORP.
K001421 05/05/2000 ONTRAK TESTCUP 501, MODEL 3016633 ROCHE DIAGNOSTICS CORP.
K051376 05/26/2005 ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE Roche Diagnostics
K012396 07/27/2001 ONTRAK TESTCARD 9 ROCHE DIAGNOSTICS CORP.
K032311 07/28/2003 ROCHE DIAGNOSTICS OMNI S ANALYZER ROCHE DIAGNOSTICS CORP.
K032437 08/07/2003 CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS ROCHE DIAGNOSTICS CORP.
K122733 09/06/2012 V2F ANTERIOR FIXATION SYSTEM ZIMMER SPINE, INC
K092940 09/24/2009 COAGUCHEK XS PLUS PST SYSTEM ROCHE DIAGNOSTICS CORP.
K983510 10/07/1998 CHEMSTRIP 101 URINE ANALYZER BOEHRINGER MANNHEIM CORP.
K033491 11/04/2003 ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS ROCHE DIAGNOSTICS CORP.
K093460 11/06/2009 COAGUCHEK XS PRO SYSTEM Roche Diagnostics
K033548 11/12/2003 ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER ROCHE DIAGNOSTICS CORP.
K093555 11/17/2009 COBAS U411 TEST SYSTEM Roche Diagnostics
K994017 11/26/1999 ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 ROCHE DIAGNOSTICS CORP.
K994020 11/26/1999 ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 ROCHE DIAGNOSTICS CORP.
K994030 11/26/1999 ONTRAK TESTCUP 5, CAT. 07 6481 7 ROCHE DIAGNOSTICS CORP.
K994164 12/09/1999 ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 ROCHE DIAGNOSTICS CORP.
K994165 12/09/1999 ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 ROCHE DIAGNOSTICS CORP.
K003865 12/13/2000 COBAS INTEGRA AMPHETAMINES ROCHE DIAGNOSTICS CORP.
K994349 12/23/1999 COAGUCHEK S SYSTEM, MODEL 2138280 ROCHE DIAGNOSTICS CORP.
K990337 02/03/1999 ONTRAK TESTCUP-5 M2K ROCHE DIAGNOSTICS CORP.
K990409 02/09/1999 ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) ROCHE DIAGNOSTICS CORP.
K990418 02/10/1999 ONTRAK TESTCUP-ER M2K ROCHE DIAGNOSTICS CORP.
K983503 10/06/1998 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 BOEHRINGER MANNHEIM CORP.


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