FDA 510(k) Applications Submitted by KATHRYN BABKA POWERS

FDA 510(k) Number Submission Date Device Name Applicant
K030579 02/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML BECTON, DICKINSON & CO.
K031699 06/02/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML BECTON, DICKINSON & CO.
K031984 06/26/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML BECTON, DICKINSON & CO.
K022129 07/01/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML BECTON, DICKINSON & CO.
K032153 07/14/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML BD DIAGNOSTIC SYSTEMS
K023273 10/01/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML BECTON, DICKINSON & CO.
K023527 10/21/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML BECTON, DICKINSON & CO.
K033560 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON DICKINSON & CO.
K033784 12/04/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML BECTON DICKINSON & CO.
K024152 12/17/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML BECTON, DICKINSON & CO.
K033907 12/17/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML BECTON, DICKINSON & CO.
K031429 05/06/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML BD DIAGNOSTIC SYSTEMS
K972156 06/09/1997 QUIX RAPID E. COLI O157 STRIP TEST GUARDIAN SCIENTIFIC, CORP.
K032655 08/28/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML BECTON, DICKINSON & CO.
K954994 10/31/1995 TRUST GUARDIAN SCIENTIFIC, CORP.
K954995 10/31/1995 QUIX RAPID CHOLERA STRIP TEST GUARDIAN SCIENTIFIC, CORP.
K030091 01/10/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML BD DIAGNOSTIC SYSTEMS
K052224 08/16/2005 BD PROBE TEC URINE PRESERVATIVE TRANSPORT BECTON, DICKINSON & CO.
K023858 11/20/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact