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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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