FDA 510(k) Applications Submitted by THERESA AMBROSE BUSH

FDA 510(k) Number Submission Date Device Name Applicant
K070172 01/18/2007 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE DIAGNOSTICS CORPORATION
K070174 01/18/2007 AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY ROCHE DIAGNOSTICS CORPORATION
K061683 06/15/2006 TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K062203 08/01/2006 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K062239 08/02/2006 GLUCOSE HK NEW FORMULATION TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K063684 12/12/2006 COBAS LITHIUM ROCHE DIAGNOSTICS CORP.
K063823 12/26/2006 COAGUCHEK XS PT CONTROLS ROCHE DIAGNOSTICS CORP.
K071041 04/12/2007 COAGUCHEK XS PLUS SYSTEM Roche Diagnostics
K062925 09/28/2006 COAGUCHEK XS SYSTEM ROCHE DIAGNOSTICS CORP.
K092322 08/04/2009 ELECSYS RUBELLA IGM IMMUNOASSAY Roche Diagnostics
K072617 09/17/2007 ELECSYS RUBELLA IGG IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K072714 09/25/2007 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K073501 12/13/2007 ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG ROCHE DIAGNOSTICS CORP.


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