FDA 510(k) Applications Submitted by UNIPATH LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K962296 06/12/1996 STREPTOLEX-STAT UNIPATH LTD.
K964487 11/07/1996 IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964491 11/07/1996 NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964492 11/08/1996 CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964490 11/08/1996 AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964489 11/08/1996 CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964493 11/08/1996 OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964495 11/08/1996 CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964496 11/08/1996 CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC UNIPATH LTD.
K964501 11/08/1996 SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K964512 11/08/1996 CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD.
K060128 01/18/2006 CLEARBLUE EASY DIGITAL PREGNANCY TEST UNIPATH LTD.
K960316 01/23/1996 CLEARBLUE EASY UNIPATH LTD.
K990223 01/25/1999 MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR UNIPATH LTD.
K990262 01/27/1999 CLEARPLAN EASY HOME PREGNANCY TEST UNIPATH LTD.
K040329 02/11/2004 MODIFICATION TO E.P.T. PREGNANCY TEST UNIPATH LTD.
K040341 02/12/2004 CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST UNIPATH LTD.
K030659 03/03/2003 CLEARBLUE EASY DIGITAL PREGNANCY TEST UNIPATH LTD.
K981207 04/02/1998 CLEARPLAN EASY FERTILITY MONITOR UNIPATH LTD.
K981271 04/07/1998 CLEARPLAN EASY OVULATION TEST UNIPATH LTD.
K050930 04/14/2005 E.P.T. CERTAINTY PREGNANCY TEST UNIPATH LTD.
K041404 05/26/2004 CLEARBLUE EASY EASY READ PREGNANCY TEST UNIPATH LTD.
K981946 06/03/1998 CLEARVIEW IM UNIPATH LTD.
K051638 06/20/2005 INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC UNIPATH LTD.
K061769 06/23/2006 E.P.T. CERTAINTY 1-STEP PREGNANCY TEST UNIPATH LTD.
K042280 08/23/2004 FACT PLUS ONE-STEP PREGNANCY TEST KIT UNIPATH LTD.
K032939 09/22/2003 EPT CERTAINTY PREGNANCY TEST UNIPATH LTD.
K993333 10/04/1999 CLEARPLAN EASY II HOME PREGNANCY TEST UNIPATH LTD.
K993703 11/02/1999 CLEARVIEW EASY HCG PREGNANCY TEST UNIPATH LTD.
K023699 11/04/2002 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST UNIPATH LTD.
K955067 11/06/1995 CLEARVIEW C. DIFF A UNIPATH LTD.
K033658 11/21/2003 E.P.T. PREGNANCY TEST UNIPATH LTD.
K013372 10/11/2001 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST UNIPATH LTD.
K013874 11/21/2001 CLEARPLANE EASY OVULATION TEST UNIPATH LTD.


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